Legal Aspect in Pharma: Project On

PHRAMA LEGAL ASPECT SANDESH BHOIR
Project on,
Legal Aspect in
Pharma
Done by,
Sandesh Bhoir
PGDM-HCPM
IES Management College,
Bandra.
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KEY LEGISLATIONS
Introduction:- Indian drug and pharmaceuticals is highly regulated given its

strategic importance and the degree of public interest involved. India comes out
with policy statements periodically outlining its stand on various issues. It last
came out with a policy statement in 2002. The Department of Chemicals and
Petrochemicals in the Ministry of Chemicals and Fertilizers supervises the
pharmaceutical industry through several acts and enforcing bodies. The Drugs
Controller of India (DCI) is the enforcing body at the central level while each state
has a Food and Drug Administration Department to regulate at the state levels.
National Pharmaceutical Pricing Authority (NPPA), meanwhile, looks after pricing
related issues. Import tariffs play a decisive role in shaping the competitive scene
in the country while excise duties impact margins and selling prices. These issues
and more are covered in the following paragraphs.
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The Drugs and Cosmetics Act, 1940
This act deals with manufacture and sale of drugs. It regulates import,
manufacture, distribution and sale of drugs and cosmetics. In 1937, a bill was
introduced in Central Legislative Assembly, upon recommendations of a Drugs
Enquiry Committee, to regulate import of drugs into British India. The Drugs and
Cosmetics Bill was passed by the Central Legislative Assembly and after receiving
the assent (agree) of the Governor General on 10th April, 1940, became Drugs and
Cosmetics Act, 1940. Between then and now, there have been many amendments
to the original act. The latest amendment in 1986 is called The Drugs and
Cosmetics (Amendment) Act, 1986. This legislation applies to the whole of India
and governs (rule on) all notified drugs and cosmetics, whether imported or made
in India. It is enforced by the Department of Chemicals and Petrochemicals.
Schedule Y of Drugs and Cosmetic Act, 1945, was amended on January 20, 2005
to make reporting of adverse events from clinical trials clear and unambiguous.
Drugs and Cosmetic Rules 1995, contains the list of drugs for which license is
required by manufacturer, importers, and exporters. Recently in vitro blood groups,
sera and in vitro diagnostic devices for HIV, HBsAg, and HCV are also included in
schedule CI. All imported drugs in indigenous manufacturers have to register to
control over the quality of imported as well as locally manufacturing kits.
The Drug and Cosmetic Act is mainly aimed to regulate, all medicines (Ayurvedic,
Siddha, and Unani) for internal or external use of human being or animals and all
substances (other than food) intended to be used for or in the diagnosis, treatment,
mitigation or prevention of any disease or disorder in human beings or animals
including preparation applied on human body or to destroy insects. Even the
central or state governments have power to make rules and appoint inspector to
control or inspect any drug or cosmetic for its standardization and safety which can
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be tested in the central or state drug laboratory. The government can prohibit
manufacturing, importing or selling of any drug or cosmetic. Violation of law by
any person or corporate manager or owner is liable for punishment for a term
which may extend to 3-10 years and shall also be liable to fine which could be Rs.
500 or Rs. 10,000 or both.
New Amendment- 2009

Drug controller general of India (DCGI) has taken special initiation for providing
better facilities, which is dedicated for controlled environment and is named as
pharma Zone. It is maintained within the cargo premises at airports and seaports
for proper storage of pharmaceuticals products. The Central Drugs Standard
Control Organization (CDSCO) has initiated steps to facilitate the creation of a
Pharma Zone in all major Airports and Sea Ports.
Pharma Zone: A separate dedicated temperature and atmosphere controlled

area to maintain the safety, efficacy and quality of imported and export
drugs / Pharmaceutical products in line with the product requirements and
GMP compliances with the cargo (shipment/ goods) premises of ports.
The Medicinal & Toilet Preparations Act, 1955 with Rules, 1956
This act enables levy and collection of duties of excise on medical and toilet
preparations containing alcohol, opium, Indian hemp or other narcotic drug or
narcotic. The rules deal with manufacture, warehousing, licensing and interstate
movement of medicinal and toilet preparations and other narcotics drugs. It lists
medicines and toilet preparations containing alcohol that are liable to be used as
ordinary alcohol beverages by consumers.
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The Drug Policy, 1986

Drug Policy of 1986, titled ‘Measures for Rationalization, Quality Control and
Growth of Drugs and Pharmaceuticals Industry in India,’ aims at ensuring easy
availability of essential and life savings drugs of good quality at a reasonable price
and strengthening the quality and quantity of drug production through policy
interventions. Drug Policy prescribes a framework for quality control and rational
use of drugs. Broadly, the policy covers all facets of the pharmaceutical industry
such as quality, investment, pricing, Research & Development (R&D), and
licensing.
The Essential Commodities Act, 1955

The Essential Commodities Act, 1955, ensures easy availability of essential
commodities to the consumer and protects the consumer from exploitation of
unscrupulous traders. This act covers production and supply of essential
commodities for maintaining or increasing supplies and for securing their equitable
distribution and availability at fair prices. Essential Commodities Act is
implemented by State Government or Union Territory Administrations under
active supervision of the Central Government.
Indian Patents Act, 1970

This Act covers patent rights and exclusivity (distinctiveness) of the patent holders
to manufacture, sell and distribute the products in India. Till now only process
patent were granted under this Act for foods, medicines, drugs and substances
prepared or produced by chemical processes. There are several amendments in this
Act to bring it to international standards.
• The Patents (Amendment) Act, 1999 [Act 17 Of 1999] With Patent Rules, 1972
• The Patents (Amendment) Act, 2002
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• The Patents (Amendment) Bill, 2003

• The Patents (Amendment) Ordinance, 2004
• The Patents (Amendment) Act, 2005
From January 2005, product patent is adopted in accordance with Trade-Related
Aspects of Intellectual Property Rights (TRIP) provisions under WTO agreement.
The Drugs Price Control Order, 1995

Drug Price Control Order (DPCO), 1995 is an order issued by the Government
of India under Section 3 of the Essential Commodities Act, 1955 to regulate the
prices of drugs. The order lists price-controlled drugs, procedures for determining
drug prices, method of implementing prices fixed by government and penalties for
contravening provisions among other things.
DPCO is implemented by National Pharmaceutical Pricing Authority (NPPA).
Good Manufacturing Practices:-

Good Manufacturing Practices (Schedule M) prescribes standards for
manufacturing facilities and processes. It lists requirements that facilities such as
premises, plants, equipments and materials need to follow. The government has
issued a notification on December 11, 2001 making cGMP mandatory under
schedule M of the Indian Drugs and Cosmetics Act, 1940 and finally fixed July 1,
2005 as the deadline for the compliance of the norms. This ensures that the drugs
manufactured in India are of world standards.
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The Pharmacy Act, 1948
This Act regulates the profession of pharmacy. It deals with various pharmacy
issues such as professional education and requirements for registration.
Regulatory Bodies
1. The Drugs Controller of India
The Drugs Controller of India (DCI) comes under the purview of Ministry of
Health. It is a major body in the pharmaceutical industry governing issues such as
product approval and standards, clinical trials, introduction of new drugs, and
import licenses for new drugs. Its major functions include:
 Controlling quality of imported drugs
• Coordinating activities of State Food and Drug Administration
• Enforcing new drug legislation
• Granting approval to new drugs
2. State Food and Drug Administration

The State Food and Drug Administration (SFDA) monitor manufacture and sale of
pharmaceuticals in their respective states. They control clinical trials carried out by
companies in their jurisdiction. However, approvals for setting up manufacturing
facilities, and obtaining licenses to sell and stock drugs are provided by the state
governments only.
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3. National Pharmaceutical Pricing Authority

National Pharmaceutical Pricing Authority (NPPA) was established on August 29,
1997 as an independent body following the recommendations of Cabinet
Committee after the review of Drug Policy in September 1994. It has been
entrusted with the task of fixation/revision of prices of bulk drugs and
formulations, enforcement of provisions of the DPCO, and monitoring the prices of
controlled and decontrolled drugs in the country.
The following are the functions of the NPPA:
􀂾 It deals with all legal matters arising out of the decisions of the authority of
DPCO.
􀂾 It mainly monitors the availability of drugs, identify shortages, if any, and to
take remedial steps
􀂾 It mainly collects/ maintains data on production, exports and imports, market
share of individual companies, profitability of companies etc., for bulk drugs and
formulations
􀂾 It undertakes and/ or sponsor relevant studies in respect of pricing of drugs/
Pharmaceuticals.
􀂾 It recruits/ appoints the officers and other staff members of the authority, as per
rules and procedures laid down by the government
􀂾 To give advice to the central government on changes/ revisions in the drug
policy.
􀂾 To render assistance to the central government in the parliamentary matters
relating to the drug pricing
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4. Department of Chemicals and Petrochemicals

Department of Chemicals and Petrochemicals under the Ministry of Chemicals and
Fertilisers monitor regulatory bodies in accordance with policies and legislation.
SFDAs are responsible for enforcement of the policies at the state level. The
department of chemicals and petrochemicals has the final word on all issues related
pharmaceutical industry.
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The structure of the department as given in figure 8.1 is mainly headed by the
Ministry of Chemical and Fertilisers, followed by the Minister of state. Under the
Minister of the State, there are four members, which include two Joint Secretaries
and one Economy Advisor and one Deputy Director General. In between the State
Minister and Joint Secretary there is an additional Secretary for financial.
Foreign Investment promotion board

Foreign Investment Promotion Board (FIPB) promotes and coordinates foreign
investment under the guidance of Ministry of Industry. It receives investment and
collaboration proposals and based on the prevailing government policy, either
approves or rejects them. A rejection does no disqualify an applicant from applying
again. Proposals up to Rs. 6 billion need the approval of Industry Minister, while
proposals above that limit need the approval of the Cabinet Committee on Foreign
Investment.
FIPB provides a single point clearance for foreign investments with guidance on
products, licensing and collaboration terms. While granting approval, FIPB may
impose restrictions on certain activities or prescribe lock-in period for foreign
equity. The documents that need to be enclosed with application process include
the annual report, corporate profile and product profile. Fifteen copies of the
application need to be submitted to FIPB. The application is circulated among
ministries that are related to the proposal and their concerns are noted, before a
decision is taken.
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Central Drugs Standard Control Organization

The Central Drugs Standard Control Organization (CDSCO) has four zonal offices
at Mumbai, Kolkata, Chennai, and Ghaziabad. The zonal offices work in close
collaboration with the State Drug Control Administration and assist them in
securing uniform enforcement of the Drug Act and other connected legislations, on
all India basis. As per the Drug and Cosmetic Act, the state government is
responsible for the regulation of the manufacture, sale and distribution of drugs,
while the central government is responsible for the approval of new drugs, clinical
trials in the country. The functions of the drug control administration undertaken
by the both central and state government are given below Functions of Central and
State Government Statutory Functions of the Central Government
• Laying down standards of drugs, cosmetics, diagnostics and devices
• Laying down regulatory measures, amendments to Acts and Rules
• To regulate market authorisation of new drugs
To regulate clinical research in India
• To approve licenses to manufacture certain categories of drugs as Central Licence
Approving Authority i.e. for blood banks, large volume parenterals and vaccines
& sera.
• To regulate the standards of imported drugs
• Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs
Consultative Committee (DCC)
• Testing of drugs by Central Drugs Labs
• Publication of Indian Pharmacopoeia.
Other functions of the Central Government

Coordinating the activities of the State Drugs Control Organizations to achieve
uniform administration of the Act; and policy guidance
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• Guidance on technical matters

• Participation in the WHO GMP certification scheme
• Monitoring adverse drug reactions (ADR)
• Conducting training programmes for regulatory officials and govt analysts
• Distribution of quotas of narcotic drugs for use in medicinal formulations
• Screening of drug formulations available in Indian market
• Evaluation/Screening of applications for granting No Objection Certificates for
export of unapproved/banned drugs
Statuary Functions of the State Government

Licensing of drug manufacturing and sales establishments
• Licensing of drug testing laboratories
• Approval of drug formulations for manufacture
• Monitoring of quality of drugs & cosmetics, manufactured by respective state
units and those marketed in the state
• Investigation and prosecution in respect of contravention of legal provisions
• Pre- and post- licensing inspection
• Recall of sub-standard drugs
Central Drug Authority

Presently, Indian regulatory environment is in the evolution. In January 2007, the
central government had approved for the formation of the Central Drug Authority
(CDA). The organizational structure of CDA is as similar to the US Food and Drug
Administration (USFDA). It is a very strong, independent, empowered, and well
equipped with professional managed body. CDA facilitate in upgradation of the
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national drug regulator, uniformity of licensing and speed up the process with
enforcement and improvement of drug regulations.
The administration structure of the CDA consists of 3 Joint Drug Controllers, 2
Deputy Drug Controllers, 6 Assistant Drug Controllers, 50 Drug Inspectors, 5
Technical Experts, 1 Administration Officer, and 1 Accounts Officer.
The following are the responsibilities of Central Drug Authority:
• New drug approvals and clinical trials
• Regulatory affairs and environment
Price Controls
Drug Price Control Order (DPCO) was first introduced in 1970 in the country
with the aim of keeping prices of essential drugs low. Later it went through a series
of revisions in 1979, 1987 and 1995. Thanks to DPCO, drug prices in India are
one of the lowest in the country.
DPCO has been blamed for among other things depressing profits of companies
and together with inadequate patent protection suppressing foreign direct
investment. Over a period of time, government has been relaxing price controls.
The number of drugs under DPCO control has come down from 370 in 1979 to 143
in 1987 to 74 in 2005. As per the proposed pharmaceutical policy, there is a plan to
bringing 354 essential drugs under price control in 2008 by NPPA.
According to DPCO, 1995, bulk drug prices are fixed by NPPA to ensure
availability at a fair price from different manufacturers. These prices are fixed from
time to time by notification+ in the official gazette. All formulations containing
these bulk drugs either in a single or combination form fall under the price control
category. New Drug Policy 2002, however, brings bulk drugs or formulations
under price control only if they meet the following criteria:
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If a manufacturer has an annual turnover of Rs. 250 million and a single firm has a
market share of 50% or above
• It has a turnover of Rs. 100–250 million and a single formulator has a market
share of 90% or more. Earlier these limits were lower. A turnover of Rs. 40 million
instead of Rs. 250 millon in case of a formulator having a market share of 50% or
above. A turnover of Rs. 10 million instead of Rs. 100–250 millon and if a
formulator had 90% share of the market or above these drugs are controlled drugs.
Now only 74 out of 500 commonly used bulk drugs are under statutory
price control. Drugs where there is sufficient market competition i.e. where there
are at least five bulk drug producers and at least 10 formulators and where none
has more than a 40% share of retail trade, price control is not mandated by the
government. Such drugs falling outside government price control and are called
decontrolled drugs However, genetically engineered drugs produced by
recombinant DNA technology and specific cell/issue targeted drug formulations
will not be under price control for five years from the date of manufacture in India
Pricing of Scheduled Bulk Drugs

Prices excluding local taxes of scheduled bulk drugs are fixed to provide a post-tax
return of 14% on net worth or a 22% return on capital employed (fixed assets plus
working capital).
The time frame for the granting price approvals for scheduled bulk drugs is for
four months from the date of the receipt of the complete prescribed information.
For a new plant, an internal rate of return based on long term marginal costing is
allowed. For a bulk drug produced from basic stage, a post-tax return of 18% on
net worth or a return of 26% of capital employed is allowed. The retail prices of
scheduled drugs manufactured in India are calculated based on basis of following
pricing formula.
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Retail Price = (Material cost + Conversion Cost + Packing Material Cost +

Packing Charges) x (1 + Maximum Allowable Post-manufacturing
Expenses/100) + Excise Duty
Pricing of Scheduled Formulations Imported into India

The landed cost of the goods is considered adding cost with inward freight and
clearing charges and import duty. Additionally 50% more is added to cover
distribution cost including trade margins and profit to arrive at the retail price.
Sales taxes, if any, are allowed to add separately. The price to the retailer must be
approved retail price less 16%. The margin to the wholesaler should be 8%. There
is no restriction on the price overseas manufacturer charges to the importer on
which the price will be based.
Pricing Regulations
Price Approval: No imported scheduled formulation can be sold or disposed
without prior approval of price from NPPA. Marketing of new pack, new
formulation or new dosage form without obtaining prior approval of its price from
NPPA is not allowed. When a manufacturer introduces a formulation similar to an
existing one in a new pack, the price is reworked based on the norms that the
NPPA may announce. In other cases, the importer or manufacturer has to file
details justifying the price in the appropriate form and has to receive NPPA
approval.
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The approved prices may be same or lower than applied. A similar procedure
applies to price revisions.
Price Fixing: NPPA is given power to fix ceiling price of scheduled formulations,
based on the cost structure or efficiency of the bulk drug manufacturers. The
ceiling price can be reconsidered and changed by the NPPA on its own or on
application made by a manufacturer.
While fixing the price, the pre-tax return of the manufacturer or importer should
not exceed the pre-tax return specified in the third schedule to the DPCO. The pre-
tax return rates vary as per case from 8% to 13%. New drug, which has not been
produced elsewhere, if developed through indigenous R&D, would be outside
price control for 10 years from the date of commercial production in favour of
company Filing of Price Lists: In case of scheduled formulations, manufacturer
must file a price list of all the prices fixed with the State Drug Controllers, dealers
and government along with NPPA official price notification reference. The price
list should be prominently displayed by dealers in their premises. Also in case of
non-scheduled formulation, the circulation of price lists is mandatory.
Price Labelling: Rules state all packages of formulations (the outer container) must
bear the retail price (whether fixed by NPPA or not) with the words “retail price
not to exceed” preceding the price and the words “local taxes extra” after the price.
Intellectual Property Rights

Indian Patents and Designs Act were passed in 1911 and several amendments were
made to this act between 1911 and 1970 and then finally, The Patent Act, 1970
was passed. India is a signatory to the Paris Convention and the Patent Cooperation
Treaty, 1970. The Patent Act, 1970 gives the holder exclusive rights to
manufacture, sell and distribute the product in India. For foods, medicines, drugs
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and substances prepared or produced by chemical processes, only process patents

are granted.
Interestingly, India had a product patent regime for all inventions under Patents
and Designs Act, 1911. However, in 1970, Indian government introduced new
Patents Act, excluding pharmaceuticals and agrochemical products from product
patents—providing the opportunity for Indian players to reverse engineer drugs
and discouraging multinationals from playing a greater role in Indian market. Now
any manufacturer can produce a molecule under patent protection in other
countries through a different process and sell it in the Indian market without any
legal challenge by the patent holder. The Act provided 5 to 7 years of process
protection for pharmaceuticals. The party, however, ended in January, 2005, with
Indian market embracing product patents.
The third amendment to the Patents Act, 1970 was introduced through the Patents
(Amendment) Ordinance, 2004 w.e.f. January 1, 2005. This ordinance was later
replaced by the Patents (Amendment) Act, 2005 (Act 15 of 2005) on April 4, 2005,
which was brought into force from January 1, 2005. Salient features of this
amendment are,
• Extension of product patents to all fields of technology including food, drugs,
chemicals and micro organisms.
• Deletion of the provisions relating to Exclusive Marketing Rights (EMRs).
Introduction of a provision for enabling grant of compulsory licence for export of
medicines to countries which have insufficient or no manufacturing capacity to
meet emergent public health situations.
• Modification in the provisions relating to opposition procedures with a view to
streamlining the system by having both pre-grant and post-grant opposition in the
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Patent Office
• Strengthening the provisions relating to national security to guard against
patenting abroad of dual use technologies
• Rationalization of provisions relating to time-lines with a view to introducing
flexibility and reducing the processing time for patent application.
The Indian Patents Act, 1970 has undergone a thorough recast following various
international treaties including the TRIPS Agreement. The life of a patent has now
been increased to 20 years uniformly. India is a member of the following
international organizations and treaties in respect of patents:
◊ World Trade Organization (WTO)
◊ Convention establishing World Intellectual Property Organization (WIPO)
◊ Paris Convention for the Protection of Industrial Property
◊ Patent Co-operation Treaty (PCT)
◊ Budapest Treaty
Legal Procedure:- In India, patents need to be registered with Controller General of

Patents, Designs and Trade Marks. This application is filed with a provisional
specification. The complete specification should be filed in the next 12 to 15
months. The patent application and specifications are studied by the examiners.
Usually, it takes 18 months to examine the application. If the specification is
accepted after examination, the notice of patent is advertised in the government’s
official gazette. Three month’s notice time is given to opposition to file objections.
The patent applicant, in turn, needs to address objections within a month. If
objections are successfully dealt with, then the patent is sealed. A patent date is
given on the date when the complete specification is filed. For items of food or
medicine, the process patent is granted for five years from the date of sealing or
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seven years from the date of the patent, whichever is earlier. Patents can be legally
licensed to other parties, for use in India or any part of the country.
From 2005 onwards, the patents of outside companies are protected through EMR
in India. EMR is not given for items based on Indian system of medicine
(Ayurvedic or Unani) or if the items are already in the public domain. EMR is
granted to an item which is already approved to be sold and distributed in a
convention country (A convention country is the country with which the Indian
Government has a reciprocal arrangement for dealing with patent applications).
EMR is also granted if the invention has been made on Indian ground and a
process patent has been applied for and granted on or after January 1, 1995.
Compulsory Licensing and Revocation of EMR

The provision of compulsory license states that two years from the date of approval
of EMR, any one can apply to the controller alleging the unmatched requirement of
the public with regard to that item or unavailability at a reasonable price and may
request for a compulsory license to sell or distribute that item. The controller will
order the EMR holder to grant a license to the applicant for sale in case the
application is justified. The controller considers the time that passed since the date
of EMR approval, the ability of the applicant to sell or distribute to the public and
the capacity of the applicant to provide capital for the operation.
The controller also has powers to revoke an EMR any time in the public interest.
The central government may sell or distribute the item reserved for EMR by itself
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or through any other person (other than EMR holder) in public interest and restrict
selling price on recommendations of an approved authority.
Permission for residents to apply for patents outside India

After amendment in law, Indian residents are permitted to apply for patent abroad
without permission of the controller. Earlier, written permission of the controller
was necessary.
Trademarks
Trade and Merchandise Marks Act, 1958 regulates trademark issues in India.
Registered trademarks are valid for a period of seven years and the possibility of a
renewal exists. Now only goods and not services are eligible for registration. For
any item, trademarks should not be objectionable from religious or social point of
view. The trademarks should not be registered earlier or applied to be registered in
India. The trademark can be registered even if the item is not produced or sold in
India.
Legal procedure: Applications are filed with Trade Mark Registry Office. In the
first step of application, a search application is filed to determine whether proposed
registered trademark is already registered by someone else or whether an
application for the same is pending for approval. Thereafter, if the search proves
trademark as identical the applicant is then given a registration number in few
months time and then the examination process begins which is specified to be done
with in a year by law. Once the trademark is cleared by the examiner, notice
inviting objections is to be published in the Trademark Journal, a government
publication. The law gives 3 to 4 months time to consider the objections. After
objections, the applicant has two months to reply, failing which it will be assumed
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that he has abandoned the application. Then, after six months, the certificate of
registration is received. However, when registration is granted, the effective date of
start is the date of the original application. With regard to convention countries, a
person of that country is allowed to apply for registration within six months of its
registration in its home country. He/she would be deemed to have been registered
in India as of the date of his/her home country application.
Manufacturing
Manufacturing License: License is a must for any drug to be manufactured in
India. Manufacturing is considered to be any process or part of a process for
making, altering, ornamenting, finishing, packing, labelling, breaking up or
otherwise treating or adopting any drug with an intention to sale or distribution. It
does not include dispensing or packing at the retail sale level. A license is required
for each such location at which drugs are to be manufactured, and also for each
drug to be manufactured. License need to be renewed periodically after validity.
Drug and Cosmetic Act gives outline of the Good Manufacturing Practices (GMP)
and requirements of premises, plant and machinery. The items covered under the
Act are: locations and surroundings, buildings, water supply, disposal of waste,
requirements for sterile products manufacturing areas (areas, access, and surfaces),
working space and storage areas, health clothing and sanitation of workers,
medical services, and equipment standards. It also includes rules for maintenance
of raw materials and records, master formula records, and batch manufacturing
records. Manufacturing operations and controls are also specified,
including general controls, precautions against contamination and mix-up,
reprocessing and recovery, product containers and closures, labels and other
printed materials. Distribution records and records of complaints and adverse
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reactions are also part of it. Quality control system requirements include functions
of the quality control department to coordinate.
Drug and Cosmetic Act also specifies other conditions for the grant or renewal of a
license:
• Competent technical staff in
pharmacy/pharmaceutical/chemistry/science/chemical
engineering/chemical technology/equivalent foreign qualification with experience
in drug manufacturing experience.
• Requirements of the testing laboratory and qualifications of the head of the
testing unit.
Industrial Licensing
For certain drugs, manufacturing license from central government, in accordance
with Drug Policy and Industrial Policy is required. The number of drugs in this
category has gone down recently and only drugs that involve use of recombinant
DNA technology, using nucleic acids as the active principles and formulations are
in this category. The applicant in these cases has to apply for an industrial license.
A Letter of Intent (LOI) or in-principle approval is granted if the application is
satisfactory and the applicant needs to set up the factory within a specified period.
The LOI is converted into an Industrial License (IL) once the factory is established
to the satisfaction of the authorities. IL specifies various conditions like the annual
capacity up to which the unit can manufacture the licensed item. All other
manufacturing units need to file an Industrial Entrepreneur’s Memorandum (IEM)
with details of the proposed items to be manufactured, capacity, location, source of
technology, raw material requirement, the process description
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and other details.
Additional Approvals/Registration
Other additional approvals or requisites for manufacturing include:
• License for import of capital goods other than those freely importable under the
Import Policy
• License for import of raw materials other than those freely importable under the
Import Policy
• Registration under Factories Act
• Lease or purchase of land
• Clearance from Pollution Control Board
• Registration under Labour Laws
• Building permissions
• Securing supply of electricity and power
• Excise duty registration
• Sales tax registration
• Explosives license
• License to store petroleum products
• Registration under Boilers Act
• Registration with the State Director of Industries
• Registration under Standards of Weights and Measures Act.
All these formalities are to be complied with at the state or local government level,
where the factory is located except import licensing formality.
Imports
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Imports into India are governed by Foreign Trade (Development & Regulation)
Act, 1992.
Under this Act, imports of all goods are free except for the items regulated by the
policy or any other law for the time being in force. Certain pharmaceuticals
products are placed on the restricted list such as: tallow fat, animal rennet, wild
animals and unprocessed ivory. These cannot be imported on grounds of security,
health and environmental protection or because they might be reserved for
production by small scale industries.. Registration with Regional Licensing
Authority is a pre-requisite for import of goods. The customs will not allow release
goods unless the importer has obtained IE Code Number from Regional Licensing
Authority.
Imports of Capital Goods and Raw Materials

Under Open General License, most capital goods, raw materials and spare parts are
generally permissible on payment of the appropriate import duty with exception for
certain specific items, where license is required. Director General of Foreign Trade
is the licensing authority under the Ministry of Commerce. A drug to be imported
requires an import license with permission of the DCI. There are no quantitative
restrictions on import of capital goods and intermediates. Import of second-hand
capital goods is permitted provided they have a minimum residual life of five
years.
Pharmaceutical Imports
Most pharmaceuticals can be freely imported into then country under foreign trade
law excepting certain drugs that need a license from Drug Controller of India.
Those products are allowed to be imported subject to expiry conditions.
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An Indian agent should be appointed by the foreign manufacturer to apply for the
import license. That agent has to be a registered entity in India. The import license
is renewed on a yearly basis expiring on December 31st every year. Importer needs
a license to stock and sell drugs. If the importer does repacking or labelling in
India, he needs a drug manufacturing license. A single license may be sufficient for
all drugs imported from one manufacturer, provided that the drugs are
manufactured at one or more than one factory functioning conjointly as a single
unit, otherwise separate license is required for drugs manufactured by each unit.
Before granting import license to any new drug, DCI approval for sale or clinical
trials is required. The foreign manufacturer must mention the Indian agent as its
authorised agent in the license application. The application should also mention the
date on which the manufacturer has started making drugs at the relevant factory
premises. The manufacturer should undertake to inform DCI of any change in
location of manufacturing and comply with the Indian standards of drugs and other
conditions of license.
New Drug Approval Process: The Drugs and Cosmetics Act, 1940 defines a drug
as: “All medicines for internal or external use of human beings or animals, and all
substances intended to be used for or in the diagnosis, treatment, mitigation or
prevention of any disease or disorder in human beings or animals, including
preparations applied on the human body for the purpose of repelling insects like
mosquitoes. Such substances (other than food) intended to affect the structure. Or
any function of the human body or intended to be used for the destruction of
vermin or insects which cause disease in human beings or animals as may be
specified from time to time by the Central Government in the Official Gazette.”
According to this Act, definition of drug also includes substances used as any
component of a drug (including empty gelatine capsules) and such medical devices
25
for treatment, mitigation and diagnosis of disease or disorder in human beings or

animals.
Drug Approval Procedure

An approval from DCI is necessary to import, market, or manufacture a new drug.
Any new drug that is not used in India previously or is not in use for less than four
years globally must get approval for import or manufacture in India by DCI. DCI is
also responsible for approval of licenses of specified categories of drugs such as
blood and blood products, IV fluids, vaccine and sera. The application for
permission to import or manufacture should be accompanied by the following
items:
• Description of drug and therapeutic class
• Clinical and pharmaceutical information
• Animal pharmacology
• Animal toxicology
• Human/clinical pharmacology (Phase I)
• Exploratory clinical trials (Phase II)
 Confirmatory clinical trials (Phase III)
• Special studies (if conducted)
• Regulatory status in other countries
• Marketing information
If the drug is already approved in other countries then some of the above
mentioned items are not required. In case a drug is already approved and marketed
abroad, then only Phase III trials may be required in India, other trials details are
exempted. Again the phase III trials should be conducted on a minimum of 100
patients across 3–4 locations in the country. There are cases where DCI agreed to
dispense with the need for local clinical trials, depending on the public interest.
26
Similarly, submission of data related to animal toxicology, reproduction studies,

teratogenic studies, prenatal studies, mutagencity and carcinogenicity may be
relaxed or modified if the drugs are in use in other country for several years (more
than 4 years) and there is adequate evidence regarding the safety of the drug. DCI
permission is required to import samples for clinical trials and to carry out the
clinical trials in India for any new drug. If the new drug is a fixed dose
combination (FDC) of an already approved active ingredients and the additions or
combinations are merely for convenience and the ingredients are unlikely to have
any significant interaction of a pharmacokinetic nature, then no additional animal
or human data are generally required. In such cases, marketing permission may be
granted if the FDC has an acceptable rationale. If first time combination is likely to
have significant interaction of a pharmacodynamic or pharmacokinetic nature, then
it is treated as a new drug.
If the new drug is a fixed dose combination (FDC) of an already approved active
ingredients and the additions or combinations are merely for convenience and the
ingredients are unlikely to have any significant interaction of a pharmacokinetic
nature, then no additional animal or human data are generally required. In such
cases, marketing permission may be granted if the FDC has an acceptable
rationale. If first time combination is likely to have significant interaction of a
pharmacodynamic or pharmacokinetic nature, then it is treated as a new drug.
Though the approval time depends on the requirement of clinical trials, it generally
takes three months to get approval after submission of the final dossier. In fact, the
actual time taken to get approval depends on effectiveness of follow-up with
authorities by local agent.
Product Standards
27
No drug can be imported, manufactured, stocked, sold or distributed unless it

meets quality and other standards laid down by Drug Controller Authority (DCA).
According to standards set by DCA, the product should comply with the
ingredients displayed in the prescribed manner on the label or container and such
other standards as may be prescribed. It ensures that the drug is not misbranded or
adulterated or spurious. General standards are set for all patent or proprietary
medicines, tablets, capsules, liquid orals, injections and ointments. In a
proprietary vitamin drug, the percentage of Active Pharmaceutical Ingredient
(API) should not be less than 90% of the labelled contents (>100% not a problem).
But it is except antibiotics and enzymes, where it should lie between 90 and 110%
of the labelled contents.
If the drug is already in the Indian pharmacopoeia (IP), the drug must meet
standards of identity, purity and strength mentioned in the current edition of the IP
or previous IP.
Standards are also prescribed for other types of drugs such as sera, antigens and
other biological products separately. According to the Act, drugs should not be
misbranded, adulterated, or spurious. A drug is considered to be misbranded, if it is
so coloured, coated, powdered or polished that damage is concealed or if it is made
to appear of better or greater therapeutic value than it really is; or it is not labelled
in the prescribed manner; or if its label or container or anything accompanying the
drug bears any statement, design or device which makes any false claim for the
drug or which is false or misleading in any particular.
Adulterated drugs are those that contain any filthy, putrid or decomposed
substance, or which has been prepared or packed under unsanitary conditions or
contaminated with filth, or contains any toxic or poisonous substance or contains
colours other than those permitted, or if it has been mixed with any substance so as
to reduce its quality or strength. According to Drug and Cosmetic Rules, permitted
28
colours are certain natural colours, artificial colours, coal tar colours, and
aluminium or calcium salts (lakes) of the permitted water soluble colours.
The power to prohibit import, manufacture or sale of any drug, including those that
are deemed as “irrational drug combinations” vests with the central government.
Labelling: Appropriate labelling is essential for sale of drugs in India. The law
demands that the label should be printed in indelible ink containing trade name and
generic name of the drug, the net contents in terms of weight, measure, volume and
likewise. The contents of active ingredients must follow the prescribed form and
manner. The name and address of the manufacturer along with the address of the
premises where the drug has been manufactured is a must. The batch number and
date of manufacture must be provided, as well as the drug license number under
which it is manufactured (if manufactured in India).
In the case of certain products including vitamin products, the label must bear the
date of manufacture, and the date of expiry of potency fixed by the manufacturer
and the import license number if the product is imported. According to Standards
of Weights and Measures Act, 1976 (SWM) and the Packaged Commodities Rules,
1977 (PCR), the label of imported package should have the name and address of
the importer, and the retail price. Under the SWM, the size and contents are to be
on the principal display panel of each container. Medical prescription is a must to
sell certain drugs, and these have to be labelled accordingly along with the
schedule of the DCA under which they are classified. Certain other drugs have
to be labelled as “to be used under medical supervision.”
Tariff Structure: The Customs Act regulates levying of tariffs on imports and
exports and frames the rules for customs valuation. The Customs Tariff Act
specifies the tariffs rates and provides for the imposition of anti-dumping and
29
countervailing duties. Most tariffs are ad valorem tax (it is a tax based on the value
of real estate and personal property) in India except few items. Tariff rates, excise
duties, regulatory duties, countervailing duties and the like are revised in each
annual budget. In the recent budget (2008-09), the great relief has been provided
for the both export and import of life saving drugs by reducing the export duty to
8% and 5% reduction in customs duty for imported Life Saving Drugs. The
pharma biotech industry has many positive changes which reduced Cenvat to
8.24%, 125% weight reduction on outsourced R&D, and reduction in custom duty
on raw materials for ELISA kits to 18.72% and specific vaccines and
Biotherapeutics to 9.36%. The tariff has not changed in bulk drugs whereas in
formulations excise duty has changed from 16.5% to 8.2% as in table 8.2.
Local Manufacturing Duty:

If any product is manufactured in India, then the tariff structure would resemble
the example set out in Table 8.3.
30
Sales Tax
Sales tax is levied on both locally manufactured drugs, life saving drugs and R&D
outsourced ones. Sales tax is levied at the point of sales on the selling price to
customer. The rate of sales tax is same for both Indian and imported items. The
budget (2008-09) has raised the allocation of funds for the healthcare sector by
15% to Rs. 165 billion, which will have positive impact on demand for healthcare
products. The 125% weighted average tax deduction for outsourced R&D expenses
is a good development for research-oriented companies. The reduction in customs
duty on some life-saving drugs and bulk drugs from 10% to 5%, as well as the
reduction of excise duty on pharmaceutical products from 16% to 8% for
formulations and the total exemption of excise duty on specific life-saving drugs
will bring gains to this sector.
Value Added Tax (VAT) was introduced in India on April 1, 2005 is hailed to
become a prominent initiative in the history of indirect tax reforms. VAT is a tax
31
leived on the value added to a product at each stage of its production, from raw
material to finished product.
VAT is presently in effect in more than 115 countries. It is an effective manner of
broadening the tax base and mobilizing large revenues in an equitable manner.
Marketing and Distribution:- Licensing of sales outlets and stock holding

Sales outlets or pharmacies or stockholding point of drug must be licensed by the
state government. If drugs are sold/stocked for sale at more than one place, a
separate license is required for each such location. The issued license remains valid
till December 31st of a calendar year, after which it needs to be renewed. The
government grants licenses based on the following conditions:
• Specified minimum area and equipment
• Compounding of drugs on the premises by a registered pharmacist
• Sales of any drugs on prescription should be under the supervision of a registered
pharmacist (qualification and experience profile are specified), and a prescription
register (for compounded drugs) or cash or credit memo book (for other medicines)
should be Maintained
• Prescription register or sale memo should contain the specified particulars of the
sale including batch number of manufacture in case of prescription drugs
• No prescription drug is to be sold without a prescription Restricted licenses are
also granted to outlets that do not need the services of a registered pharmacist and
where no compounding takes place. The outlets are allowed to use titles such as
Pharmacy or Pharmacist only if they use the services of a registered pharmacist
and maintain a pharmacy for compounding. In case of drug wholesaler and retail
outlets, registrations are required under the following Acts:
• The Shops and Establishment Act
• The Standard of Weights and Measures Act
32
• Labour Legislation
• Sales Tax
Prescription Drugs: DCA has clearly specified certain drugs to be sold only under
prescription. So it is implied that the rest can be sold without prescription as Over
the Counter (OTC). But many prescription drugs are sold without prescription,
which is a common practice as people also take medical advice from pharmacists.
Advertisement and Promotion: Prescription drugs are prohibited to advertise in the

general media like OTC drugs. Advertising options are limited to trade journals
such as chemist guides, directories, and medical magazines. Sponsorship is also
permitted. Conducting conferences in India as well as abroad in the presence of
several doctors at company cost is a common practice. The conferences make
doctors aware about the products by distributing various informative items along
with complimentary items. Making doctors aware of products through medical
representatives is also a common practice.
Regulations of Advertising: Prescription drugs apart, little advertising restrictions

apply to other drugs. But the advertisements should not claim anything
unjustifiable and in such a case complaints can be made to the Advertising
Standards Council of India (ASCI), a self regulatory body. ASCI may ask the
advertiser to withdraw or modify the advertisement if complaint is genuine.
Packing and Labelling
33
Major legislation affecting packaging and labelling are SWM and PCR. General
requirements of SWM\PCR are that the package should disclose necessary
information in a proper way.Major provisions include:
• Details such as manufacturer’s name, date of manufacture, commodity, contents,
weight, and price, should be printed on all packs.
• Display panel should be as per the rules (size, size of letters, etc.)
• Declaration of quantity as per the norms and in the prescribed manner
• The declaration of units or weight, measures or numbers as per norms
• Specified commodities should be packed in prescribed pack size, and within the
prescribed margin of error
Distribution: In India, there is no national level distribution channel. Therefore

producers or importers build a network of their own comprising carrying and
forward agents (C&F) and wholesalers. The first step in distribution is from
manufacturing site to the national depot which is run by either company or C&F
agents. C&F agents operate depots on the company’s behalf, but employ their own
staff. The goods are dispatched from company’s location to the depot. From C&F
depot, goods are sent to wholesaler’s point. The wholesaler directly pays the
company, with C&F agent getting a percentage. Wholesalers sell the goods to
various retailers—who sell them to consumers. A wholesaler receives commission
between 8–10% of the sale price. The company’s sales representatives coordinate
with both C&F agent and wholesaler to expedite sales and dispatches.
Brands: Brand names should not be used by any other party if already existing or
already registered by any other player. There is no restriction on the use of foreign
brand names on products sold within the country, whether locally manufactured or
otherwise. The brand names may even be licensed to an Indian party. The common
34
practice for brand names is to use as part of an overall foreign collaboration though
there is no restriction on having trademark agreements alone.
Restrictive Trade Practices: Monopolies and Restrictive Trade Practices Act, 1969
(MRTP) checks monopoly of industrial groups and prevents restrictive trade
practices. It deals with restrictive trade practices such as price fixing, dealership
agreements with restrictive clauses, unfair promotions, misleading advertisements,
etc.
The main regulatory body in India is
The Central Drug Standard Control Organization (CDSCO) under the Ministry of
Health and Family Welfare.
• CDSCO is presided over by the Drug Controller- General of India (DCGI), who
is in charge of approval of licenses for drugs at both the Central and state levels.
• India introduced the product patent regime, in accordance with the TRIPS
agreement, in January 2005 with an amendment to the patent act
• Foreign direct investment (FDI) up to 100 per cent is permitted through the
automatic route in drugs and pharmaceuticals.
35
DUNKEL DRAFT TEXT
PATENT ISSUES AND TRIPS OF THE DUNKEL TEXT
The General Agreement on Tariffs and Trade (GATT) was established in 1948 and
since then there have been several rounds of negotiations. The current round, the
Uruguay Round, however, is different from earlier sessions because many new
issues such as Trade-Related Intellectual Property Rights schemes have been
included in the agenda. These new issues directly impinge upon people around the
world in some form or another, said Mr B K Keayla, convenor of the Indian
National Working Group on Patent Laws at the three-day International Conference
on Patent Regimes, which took place recently in New Delhi, India (see also page
17).
The patent regime as proposed in the TRIPS text of the Dunkel Draft Text provides
for rights and rights only for the patent holders. The obligation to serve the public
interest is totally nonexistent. The leverage available to the governments in the
patent system to ensure public interest through compulsory licensing, licensing of
rights and revocation of patents have been totally set aside, said Mr Keayla.
Imports would become subject to patent-grant obligation.
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The possibility of ensuring any competitive environment will be systematically
eliminated. The aspirations of the developing countries to derive benefits from the
international trading system would be totally negated. The fact remains that the
concerns of the developing countries which were shown in the November 1990,
Draft Final Act of the Uruguay Round, were unilaterally deleted in the DDT of
36
December 1991, which now represents only the one-sided interest of the highly-
developed countries, he continued.
On the specific provisions relating to the new patent systems in TRIPS, Mr Keayla
pointed out that the DDT has been presented as a package to the contracting parties
to accept it as a whole, and that there is no specific agreement which may be even
detrimental to their national interest. This kind of outcome from negotiations on
international trading systems will have no lasting life. It will face a tremendous
resistance from all over the world when people start experiencing its impact, he
warned.
The other important aspect of the Dunkel proposal is that it is in the nature of a
self-executing treaty. All proposals contained in the DDT will have to be
implemented in the national laws and policies of sovereign countries. This is an
undemocratic feature, says Mr Keayla, which challenges the sovereign law-making
authorities in different countries.
Mr Keayla points out that Article 27 of the DDT provides that patents shall be
available for any inventions, whether products or processes, in all fields of
technology. This, he says, leaves no choice with the member countries to exclude
certain technologies and sectors of the economy from the patent system.
The scope of patentability when taken with the patent term of 20 years in the
chemical field would mean that it would be possible to extend the patent regime in
some form or other for a long time. There would be product patent protection for
20 years and then process patent for another 20 years, says Mr Keayla. In the USA,
patents are being taken for drug formulations, dosage forms and usage forms. This
kind of patent could also be taken for a further period of 20 years, he adds.
37
During the process patent regime, reversal of the burden of proof has also been
provided. The sum total of all these provisions would mean that the patent regime
for a particular product could get extended to a period possibly as long as 40-to-60
years. There will be no competitive environment. Mr Keayla believes that in such
conditions people will suffer the impact of monopolization and domestic drug
industries will have a slow death.
Article 27 also provides that patent rights would be enjoyable without

discrimination as to the place of invention, the field of technology and whether the
products are imported or produced locally. This has serious implications because a
patent holder would be able to exclude others from manufacturing by taking
product patent protection and then would resort to importation, thus establishing a
total trading monopoly.
Mr Keayla argues that sovereign governments should have the right to draw up
their own laws within the framework of the global system that may be evolved
through negotiations and keeping in view the aspirations of all.
Under Article 28, exclusive rights have been provided for the product patent holder
and the process patent holder. The significance of these exclusive rights are
important when we find that exclusive rights for imports have also been provided
for the patent holder. Here it may be difficult even for governments to import
patented products from many sources that may get established elsewhere in the
world through sub-licensing. The impact of this provision would be realized when
there are emergent conditions. This right should not be available to the patent
holder at all, according to Mr Keayla.
The instruments of compulsory licensing and licensing of rights for working of a

patent are totally nonexistent in the proposed patent regime. In place of
38
compulsory licensing, Mr Keayla says that some totally weak provisions have been
provided in Article 31, which also has a conspicuous title: "Other use without
authorization of the right holder."
Provisions contained in this article do not provide for a similar kind of authority to
the national government to ensure the working of the patent. There is some
possibility provided for authorization by governments when there is a national
emergency or other circumstances of extreme urgency, or in case of public
noncommercial use. Such authorizations have limited scope and can be terminated
when the circumstances for authorization cease to exist. Furthermore, the usage
shall be nonexclusive, nonassignable and only for the domestic market.
No one will be interested in taking up such an authorization, according to Mr

Keayla, because no one would be interested in noncommercial ventures.
Furthermore, no entrepreneurs would be developing technologies and waiting for
an emergency or contingency to occur. It takes easily three-to-four years to
develop process technologies of any new molecules. This means that the
provisions in Article 31 are virtually of no consequence, says Mr Keayla.
He says that what the industry should be asking for is clear provision for automatic
licensing of rights and compensation to the patent holder through a royalty system
for the use of the patent. Details of this mechanism can be worked out, and for this
reason, Mr Keayla advocates support of the Cartagena declaration, which was
issued by the Latin American National Pharmaceutical Industries Association,
ALIFAR, at the end of its annual meeting in Cartagena, Colombia, in June
(Marketletter June 14).
The declaration: rejects intervention by the USA to impose monopolies regarding

medicines; it alerts legislators and governments to the consequences of approving
39
such patent legislation and advocates alternative systems based on economic and
competitive freedom; it recognizes the rights of innovative companies, but supports
the idea that legislation should reconcile this with the national industries,
consumers, and with the public health objectives of each government. The
ALIFAR countries support a legal system allowing any company that can produce
medicines to do so, whilst paying the patent holder a royalty fixed by law; the
declaration also rejects the creation of artificial barriers to market access,
particularly in relation to registration and approval of medicines.
A guest speaker at this year's ALIFAR annual meeting, Mr Keayla says that the
Cartagena declaration is the only valid alternative which can be offered for final
negotiations regarding patent protection. Analysis has shown that the patent holder
would be better compensated and there would be no grudge against the strong
patent system proposed.
Mr Keayla says that the "exclusive marketing right" provision for a five-year
period, as suggested in a transitional arrangement, makes a mockery of the national
patent system which would be rendered useless.
He would like to see a clear transitional period proposed, but suggests that a ten-
year transitional period is not adequate. India took 20 years to revise the Colonial
Patent Act, the Patents and Designs Act of 1911. "If we were to demolish our own
progressive patent law (the Indian Patents Act) that has been in operation since
1970, we would need a very long period as there would be tremendous resistance,"
he commented.
The Indian industry has been able to produce basic drugs covering various
therapeutic groups, and has almost reached self sufficiency in production of bulk
40
drugs. The industry has also developed the capability of producing enough surplus
of bulk drugs for worldwide exports.
Growth In The Indian Market Since the Indian Patents Act was enacted in 1970,
the production of pharmaceutical products in India has grown more than eightfold,
from 5 billion rupees ($160.6 million) in 1974 to over 40 billion rupees ($1.3
billion) in 1991.
In recent years there has been a sharp rise in exports by the industry. In the six
years between 1985/86 and 1991/92, exports have grown from 1.4 billion rupees to
12.8 billion rupees. Exports to the USA have increased around threefold in the
period from 1991 to 1992. The domestic industry has helped greatly in not only
providing drug security, but also in getting access to foreign markets.
Significantly, out of the top five companies operating in India only one, Glaxo, is
an affiliate of a multinational company, and the rest are Indian companies.
Furthermore, 80% of the bulk drugs are produced by Indian companies.
Share Of Patented Drugs In India Therapeutic Groups % under patent
Antibiotics 40.23 Antibacterials 98.80 Systemic antifungals 25.66 Antileprotics

69.96 Cardiovasculars 40.18 NSAIDS 22.16 Tranquilizers 74.42 Anticonvulsants
65.93 Antipeptic ulcer agents 65.92 Oral antidiabetes agents 55.30 Antiasthmatic
agents 47.53 Antihistamines 21.34 Cytostatics and antileukemics 32.41
Contraceptive hormones 88.79
The table above shows that all the latest drugs are in extensive use in India and that
the US Trade Representative's claims that India's domestic industry produces no
more than 5% of patented drugs is false, says Mr Keayla.
41
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PHRAMA LEGAL ASPECT SANDESH BHOIR

Introduction:- Indian drug and pharmaceuticals is highly regulated given its

The Drugs and Cosmetics Act, 1940

New Amendment- 2009

Pharma Zone: A separate dedicated temperature and atmosphere controlled

The Drug Policy, 1986

The Essential Commodities Act, 1955

Indian Patents Act, 1970

• The Patents (Amendment) Bill, 2003

The Drugs Price Control Order, 1995

Good Manufacturing Practices:-

The Pharmacy Act, 1948

2. State Food and Drug Administration

3. National Pharmaceutical Pricing Authority

4. Department of Chemicals and Petrochemicals

Foreign Investment promotion board

Central Drugs Standard Control Organization

Other functions of the Central Government

• Guidance on technical matters

Statuary Functions of the State Government

Central Drug Authority

Pricing of Scheduled Bulk Drugs

Retail Price = (Material cost + Conversion Cost + Packing Material Cost +

Pricing of Scheduled Formulations Imported into India

Intellectual Property Rights

and substances prepared or produced by chemical processes, only process patents

Legal Procedure:- In India, patents need to be registered with Controller General of

Compulsory Licensing and Revocation of EMR

Permission for residents to apply for patents outside India

and other details.

Imports of Capital Goods and Raw Materials

for treatment, mitigation and diagnosis of disease or disorder in human beings or

Drug Approval Procedure

Similarly, submission of data related to animal toxicology, reproduction studies,

No drug can be imported, manufactured, stocked, sold or distributed unless it

Local Manufacturing Duty:

Marketing and Distribution:- Licensing of sales outlets and stock holding

Advertisement and Promotion: Prescription drugs are prohibited to advertise in the

Regulations of Advertising: Prescription drugs apart, little advertising restrictions

Packing and Labelling

Distribution: In India, there is no national level distribution channel. Therefore

DUNKEL DRAFT TEXT

PATENT ISSUES AND TRIPS OF THE DUNKEL TEXT

Article 27 also provides that patent rights would be enjoyable without

The instruments of compulsory licensing and licensing of rights for working of a

No one will be interested in taking up such an authorization, according to Mr

The declaration: rejects intervention by the USA to impose monopolies regarding

Share Of Patented Drugs In India Therapeutic Groups % under patent

Antibiotics 40.23 Antibacterials 98.80 Systemic antifungals 25.66 Antileprotics

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