The Indian Pharmaceutical Industry currently tops the chart amongst India's science- based industries with wide ranging capabilities in the complex field of drug manufacture and technology. The Indian Pharmaceutical Industry ranks very high amongst all third world countries, in terms of technology, quality and the vast range of medicines that are manufactured.
The Pharmaceutical industry has grown from mere US$ 0.3 billion turnover in 1980 to about US$ 21.73 billion in 2009-10. The country now ranks 3 rd in terms of volume of production and14 th largest by value. One reason for lower value share is the lowest cost of drugs in India ranging from 5 per cent to 50 per cent less as compared to developed countries. Indian pharmaceutical industry growth has been fuelled by exports and its products are exported to a large number of countries with a sizeable share in the advanced regulated markets of the US and Western Europe .
Many Indian companies maintain highest standards in Purity, Stability and International Safety, Health and Environmental protection in production and supply of bulk drugs even to some innovator companies. This speaks of the high quality standards maintained by a large number of Indian Pharma companies as these bulk actives are used by the buyer companies in manufacture of dosage forms which are again subjected to stringent assessment by various regulatory authorities in the importing countries. More of Indian companies are now seeking regulatory approvals in USA in specialized segments like Anti-infectives, Cardiovasculars, CNS group. Along with Brazil & PR China, India has carved a niche for itself by being a top generic Pharma player. Increasing number of Indian pharmaceutical companies have been getting international regulatory approvals for their plants from agencies like USFDA (USA), MHRA (UK), TGA (Australia), MCC (South Africa), Health Canada etc. India has the largest number of USFDA- approved plants for generic manufacture. Considering that the pharmaceutical industry involves sophisticated technology and stringent "Good Manufacturing Practice requirements, major share of Indian Pharma exports going to highly developed western countries bears testimony to not only the excellent quality of Indian pharmaceuticals but also its price competitiveness. More than 50 per cent share of exports is by way of dosage forms. Indian companies are now seeking more Abbreviated New Drug Approvals in USA in specialized segments like anti-infective, cardio vascular and central nervous system groups.
India's pharmaceutical market grew at 15.7 per cent during December 2012. Globally, Indiaranks third in terms of manufacturing pharma products by volume. According to McKinsey, the Pharmaceutical Market is ranked 14th in the world. By 2015 it is expected to reach top 10 in the world beating Brazil, Mexico, South Korea and Turkey. More importantly, the incremental market growth of US$ 14billion over the next decade is likely to be the third largest among all markets. The US and China are expected to add US$ 200bn and US$ 23bn respectively.
2.2 HISTORY OF INDIAN PHARMACEUTICAL INDUSTRY Looking back into history reveals that it was in 1930 when the first pharmaceutical company in India came into existence in Kolkatta. It is called the "Bengal Chemicals and Pharmaceutical Works". This Indian company is still there and today it is the part of five drug manufacturing companies that are owned by the government. Till the period of 60 years the pharmaceutical industry in India was overshadowed by the foreign drug manufacturing companies but with the Patent Act in 1970, the whole scenario of pharmaceutical companies in India had changed since then. With this the Indian market was more open to Indian pharmaceutical companies than the MNCs. So with this pharmaceutical companies in India started to grow in number At present there is a cut throat competition among top pharmaceutical companies in India with the native as well as MNCs. But there are certain issues that are concerning the growth of pharma companies in India. These are:Pharmaceutical drugs Mandatory licensing and failure of new paten system. Regular power cuts and inadequate infrastructure. Restricted funding. Regulatory hindrances that lead to the delays in the launch of new drug or pharma product. Too many small as well as big pharmaceutical companies and excessive competition.
2.3 INDUSTRY TRENDS All companies, including MNCs, have increased their field force in the last one year. Indian companies are entering into strategic tie-ups with MNCs to strengthen their product portfolio. Companies are expanding their presence in rural markets. Acquisitions by MNCs to gain quick foothold in the fastest growing Indian pharma market.
Most of the Pharma companies have shown considerable decline in growth in the first half of 2011. The slowdown is widely visible in the Chronic and Acute categories. Anti- invective, pain and gastro together contribute 1/3rd of the total pharma market. The pharma companies have started facing challenges in domestic market due to increase in competition from unlisted MNCs in this segment. They are rapidly expanding their field force to extend their geographical reach. Companies like Cipla, Torrent and IPCA which are mainly focused on Indian market are already feeling the heat. Growth rates of companies such as Cadila, Dr. Reddy and Ranbaxy have already come down. On the other hand Lupin and Sun are showing growth due to the shift of focus towards specialty therapies, where competition is relatively low.
Basing on the changing macro factors and economic growth Emkay Research has expected the growth estimates of the pharma companies to decrease. It cut down the domestic growth estimates for Cadila, Cipla, Dr. Reddy, IPCA, Torrent and Unichem for FY12 and FY 13 by 2% to 5% and retained the growth estimates for Lupin, Ranbaxy, Sun, GSK and Pfitzer.
A highly fragmented industry, the Indian pharmaceutical industry is estimated to have over 10,000 manufacturing units, as given by the Organisation of Pharmaceutical Producers of India. The organized sector accounts for just 5% of the industry with around 300 players, while a huge 95% is in the unorganized sector. A large number of players in the unorganized segment are small and medium enterprises and this segment contributes 35% of the industrys turnover.
In calendar year (CY) 2005, turnover of the organized sector companies aggregated to Rs 302 bn, of which 19% came from MNCs while the remaining 81% was contributed by Indian companies. Turnover of players in the unorganized segment, though difficult to assess, is estimated to be around Rs 160 bn.
The Indian pharmaceutical industry consists of manufacturers of bulk drugs and formulations. Bulk drugs include the active pharmaceutical ingredients (APIs) which are used for the manufacture of formulations. According to estimates, the proportion of formulations and bulk drugs is in the order of 75:25. There are believed to be over 60,000 formulations manufactured in India in more than 60 therapeutic segments. More than 85% of the formulations produced in the country are sold in the domestic market. India is largely self-sufficient in case of formulations, though some life saving, new-generation-technology-barrier formulations continue to be imported.
Among the therapeutic segments, the anti-infectives top domestic production in volumes. In 2005, the chronic therapy segment accounted for around 26% of the domestic formulation business, growing at a rate of 10%; faster than the acute therapy segment. The chronic therapy segment includes anti-diabetics, cardiac and neuro-psychiatry formulations. Bulk drug manufacturing is largely concentrated in Andhra Pradesh, which accounts for more than one-third of the countrys total bulk drug production, followed by Gujarat. The Indian bulk drug industry has lately been gaining signifi cant presence in the global market as foreign and multinational companies are looking to sourcing APIs and intermediates from Indian manufacturers. Factors favouring the industry are a vast resource of technical people, stateof- the-art manufacturing facilities, low cost and the advantage of the English language. As part of governments support to increase exports, duty free zones have been set up and several manufacturers of bulk drugs have been shifting their facilities to these areas. As a result, the diverse spread has now started getting consolidated and concentrated in certain regions across the country.
India has a significant share in the global generics market and is ranked third. In recent years, this segment has been facing stiff competition which makes the scale of production important to improve profitability. India has pre-dominantly been a generic player and has the potential to gain a global presence for the following key developments: Multiple branded drug patent expirations in the short term. According to IMS Health, in 2006 and 2007 a total of US$ 28 bn and US$ 20 bn, respectively, of branded sales were likely to become susceptible to the entry of generic equivalents Increasing confidence of consumers in generics in the developed markets A pro-generic sentiment from healthcare authorities driven by the pressure of containing rising healthcare costs An aging population across the world, leading to increasing demand for low cost therapies Global healthcare crisis like AIDS in the developing world, necessitating affordable medication for the masses Generic companies in India are recognizing the importance of patent expiries and are making significant incremental investments in research and drug development.
Key Strengths of Pharma Sector Low cost of innovation/Manufacturing/Capex costs/expenditure to run a cGMP compliance facility. Low cost scientific pool on shop floor leading to high quality documentation. Proven track record in design of high tech manufacturing facilities. Excellent regulatory compliance capabilities for operating these assets. Recent success track record in circumventing API/formulation patents. About 95 per cent of the domestic requirement being met through domestic production. India is regarded as a high-quality and skilled producer in the world.
2.4 GOVERNMENT INITIATIVES: Government initiatives in the public health sector have recorded some noteworthy successes over time with focus on investments related to better medical infrastructure, rural health facilities etc.
100 per cent FDI is permitted for health and medical services under the automatic route. The National Rural Health Mission (NHRM) had allocated US$ 10.15 billion for the upgradation and capacity enhancement of healthcare facilities. Moreover, in order to meet revised cost of construction, in March 2010 the Government allocated an additional US$ 1.23 billion for six upcoming AIIMS-like institutes and upgradation of 13 existing Government Medical Colleges.
As a result, FDI inflow in hospital and diagnostic centres was US$ 1.1 billion during April 2000 and November 2011, according to st Department of Industrial Policy & Promotion (DIPP) data. FDI inflow in medical and surgical appliances stood at US$ 472.6 million during the same period. And the drugs and pharmaceuticals sector has attracted FDI worth US$ 5.0 billion between April 2000 and November 2011
2.5 BUDGET 2012: Union Budget 2012-13, as expected, is positive for the pharmaceutical sector. The government has again increased budgetary allocation for healthcare spending, which would be an overall positive for the sector. Indian pharmaceutical companies have been investing on the R&D front to tap opportunities in the domestic and global markets. To encourage the same, the weighted deduction on R&D expenditure to 200% (in-house research) was extended for a further period of five years. R&D sops would continue to be positive for the sector as a whole.
Budget Proposal Impact Proposal to extend weighted deduction of 200% for R&D expenditure in an in-house facility for a further period of five years beyond March 31, 2012. Positive for all Indian pharmaceutical companies. Allocation for NRHM proposed to be increased from Rs 18,115cr in FY2011-12 to Rs 20,822cr in FY2012-13. Positive for all pharmaceutical companies. Proposal to continue to allow repatriation of dividends from foreign subsidiaries of Indian companies at a lower tax rate of 15% up to March 2013. Positive for all pharmaceutical companies, mainly Indian companies, as they generate the highest revenue from export markets. Introduced MAT on partnership firm. Would negatively impact Cadila Healthcare and Sun Pharmaceuticals. Since we have already factored in higher tax provision for FY2013, we are not changing our FY2013 estimates for both the companies.
4.5 DOMESTIC PHARMA INDUSTRY The domestic Pharma Industry has recently achieved some historic milestones through a leadership position and global presence as a world class cost effective generic drugs' manufacturer of AIDS medicines. Many Indian companies are part of an agreement where major AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine will be supplied to Mozambique, Rwanda, South Africa and Tanzania which have about 33 per cent of all people living with AIDS in Africa. Yet another US Scheme envisages sourcing Anti Retrovirals from some Indian companies whose products are already US FDA approved. Many Indian companies maintain highest standards in Purity, Stability and International Safety, Health and Environmental protection in production and supply of bulk drugs even to some innovator companies. This speaks of the high quality standards maintained by a large number of Indian Pharma companies as these bulk actives are used by the buyer companies in manufacture of dosage forms which are again subjected to stringent assessment by various regulatory authorities in the importing countries. More of Indian companies are now seeking regulatory approvals in USA in specialized segments like Anti-infectives, Cardiovasculars, CNS group. Along with Brazil & PR China, India has carved a niche for itself by being a top generic Pharma player. Increasing number of Indian pharmaceutical companies have been getting international regulatory approvals for their plants from agencies like USFDA (USA), MHRA (UK), TGA (Australia), MCC (South Africa), Health Canada etc. India has the largest number of USFDA - approved plants for generic manufacture. Considering that the pharmaceutical industry involves sophisticated technology and stringent "Good Manufacturing Practice (GMP) requirements, major share of Indian Pharma exports going to highly developed western countries bears testimony to not only the excellent quality of Indian pharmaceuticals but also its price competitiveness. More than 50 per cent share of exports is by way of dosage forms. Indian companies are now seeking more Abbreviated New Drug Approvals (ANDAs) in USA in specialized segments like anti-infective, cardio vascular and central nervous system groups.
More than 85% of the formulations produced in the country are sold in the domestic market. India is largely self-sufficient in case of formulations. Some life saving, new generation under-patent formulations continue to be imported, especially by MNCs, which then market them in India. Overall, the size of the domestic formulations market is around Rs160bn and it is growing at 10% p.a. 4.6 IMPORTS: Registration of imported drugs All drugs to be imported require their own import registration. This is independent of new the required drug registration. Foreign manufacturers must apply for registration certification for their manufacturing premises and for the individual drugs to be imported. Applications can be made by authorized agents of foreign firms in India. Import licensing: India does not permit the free import of all goods. While India is a signatory to the world trade organization (WTO), it has been given time to remove its quantitative restrictions on imports (QRs) in a phased manner, with QRs to be totally lifted by 2002 or earlier. At present most non-consumer goods items are permitted to be imported freely, while some consumer goods are permitted to be imported freely, and others are prohibited for import. Most items are classified under the international harmonized system (HIS of BTN) and categorized for import accordingly. Imports and exports are regulated by the foreign trade (Development and Regulation) act, 1992. Pharmaceutical imports: Most pharmaceuticals are still freely importable under the foreign trade law. Certain drugs may not, however, be imported except under a license given by the drug controller of india. Such products cannot be imported after the date shown on the lable as being that on which the potency would reduce or toxicity would increase beyond the standard permitted.
4.7 EXPORTS OF INDIAN PHARMACEUTICALS Over 60% of Indias bulk drug production is exported. The balance is sold locally to other formulators. Indias pharmaceutical exports are to the tune of Rs87bn, of which formulations contribute nearly 55% and the rest 45% comes from bulk drugs. In financial year 200, exports grew by 21%. Indias pharmaceuticals imports were to the tune of Rs20.3bn in FY2001. Imports have registered a CAGR of only 2% in the past 5 years. Import of bulk drugs have slowed down in the recent years. The exports of Pharmaceuticals during the year 1998-97 were Rs 49780 million. From a meager Rs 46 crores worth of Pharmaceuticals, Drugs and Fine Chemicals exports in 1980-81, pharmaceutical exports has risen to approximately Rs 6152 Crores (Prov.1998-99), a rise of 11.91% against the last year exports. Amongst the total exports of India, the percentage share of Drugs, Pharmaceuticals and Fine Chemicals during April-October (2000-2001) was 4.1%, an increase of 7%. Top 10 destinations of Indian Pharma products for the period April-December 2012 S. No. Importing country Amount (US$ million) 1 USA 1791.0 2 UK 263.9 3 Germany 243.6 4 South Africa 226.8 5 Russia 221.4 6 Brazil 165.0 7 Nigeria 154.1 8 Kenya 137.3 9 Netherlands 131.7 10 Turkey 119.0
4.8 CHALLENGES OF PHARMACEUTICAL INDUSTRY The following challenges faced by the global pharmaceutical industry also open up a number of opportunities for the Indian pharmaceutical industry: Higher healthcare costs Competition from generics Pastent expiries of blockbuster drugs Increasing R & D costs Poor all-round infrastructure is a major challance Stringent price controls Lack of data protection Tomorrows challenge is to develop new medicines that can prevent or cure currently incurable diseases. Todays challenge is to get to tomorrow and thats a tall order in itself. Rising customer expectations: The commercial environment is getting harsher, as healthcare payers impose new cost constraints on healthcare providers and scrutinise the value medicines offer much more carefully. They want new therapies that are clinically and economically better than the existing alternatives, together with hard, real-world outcomes data to back any claims about a medicines superiority. Poor scientific productivity: Pharmas output has remained at a stable level for the past decade. Using the same discovering and developing processes, theres little reason to think its productivity will suddenly soar. Cultural sclerosis: The prevailing management culture, mental models and strategies on which the industry relies are the same ones its traditionally relied on, even though theyve been eclipsed by new ways of doing business
4.9 RESEARCH AND DEVELOPMENT In no other Industry segment innovative R&D is as critical as in Pharma industry. Here, the New Drug Discovery Research (NDDR) has to keep pace with the emerging pattern of diseases as well as responses in managing existing diseases where target organisms are becoming resistant to existing drugs. The NDDR is also an expensive activity. It is encouraging to observe that at least 10 Indian companies are into new drug discovery in the areas of infections, metabolic disorders like diabetes, inflammation, respiratory, obesity & cancer. Most of these companies have increased their R&D spending to over 5 per cent of their respective sales turnovers. There is notable success from some Indian companies in out licensing new molecules in the asthma and diabetes segments to foreign companies. Introduction of Product Patent for Pharmaceuticals is an important feature for Indian Pharma R&D scenario. This has boosted the confidence of MNC Pharma companies in India where a number of western Pharma companies have already R&D collaborations with Indian Pharma companies in the field of NDDR. Some Indian companies have also got US-FDA approvals for their new molecules as Innovative New Drugs (lND). Western Pharma companies have recognized the attractiveness of India as a R&D outsourcing destination due to low cost scientific manpower, excellent infrastructure, top quality with capability to conduct modern research under GLP, GCP guidelines. Many of them have set up independent R&D centres in India. Clinical Trials to establish safety and efficacy of drugs constitute nearly 70 per cent of R&D costs. Considering the low cost of Research and Development in India, several MNC Pharma companies as well as global Clinical Research Organizations are increasingly making India a clinical research hub. In conclusion new drug discovery in India has made a promising start wherein at least five to six potential candidates in the areas of Malaria, Obesity, Cancer, Diabetes and Infections are likely to reach Phase II clinical trials.
4.10 PRODUCTION AND TRADE
The domestic bulk drug and formulation industry has been able to largely meet the domestic demand for these products. Besides, it also exports to several regions, including the EU and US. Exports currently constitute nearly 48% of the industrys turnover, and have been growing at an average 22% annually since 1994. In FY06, exports grew by an impressive 21% touching Rs 215.8 bn.
The growing demand from the domestic market and increased manufacturing activities has led to rising imports during the past few years. In FY06, imports were worth Rs 45.2 bn as against Rs 31.7 bn in FY05. The nature of imports has undergone a significant change over the years, from finished doses imported prior to the 1970s, to largely bulk drugs today.
Domestic demand has been showing significant growth; the rise in consumption being primarily attributed to the rising population, rise in income levels and increasing health awareness among people. New product launches by the Indian and multinational companies have also catalyzed market demand. Moreover, the favourable regulatory environment, increased expenditure on R&D and improved technical skills in the fi eld of chemical synthesis has also played an important role.
The increasing alliances and tie-ups of Indian companies with global players has further given a boost to Indian exports.
4.11 Pharmaceutical Export Promotion council Pharmaceutical Export Promotion Council (Pharmexcil) having its Headquarters at Hyderabad and Regional offices at Mumbai and Delhi, was set up by the Ministry of Commerce and Industry, Government of India vide Notification No 64 dated the 12th May, 2004. Under Para 3.12.1 of Export and Import Policy 2002-2007, Pharmexcil is the only Designated Agency for issue of Registration and Membership Certificates for Pharmaceutical Exports dealing in products/services like: - Bulk Drugs, Drug Intermediates, Drug Formulations, Biotechnology, Biological Products, Herbal Products (Ayurveda, Siddha & Unani ), Medicinal Plants, Homeopathy, Nutraceuticals and Physiochemical, Diagnostics, Contact Research; contract Manufacturing , Clinical Research, Surgical, Collaborative Research and Technologies/ Consultancy. Objectives The objectives of the Council (Pharmexcil) are to extend all assistance to the pharmaceutical industry in India to explore their opportunities. Towards achieving this aim, the Council is taking delegations to various countries, organizing Business meets etc. encouraging export activities by arranging fund support under MAI programmes of the Government. Services This Council is a Government sponsored single window contact to the world of Pharmaceuticals from India and an only authorized agency for issue of Registration cum Membership Certificate (RCMC) for pharmaceutical exports under Foreign Trade Policy of Government of India. Apart from this, the Council is also providing following assistance: -
(a) Trade Enquiries received from foreign Embassies /Buyers (b) Market Development assistance as provided by Ministry of Commerce for business tours to foreign countries. (c) Arrange one to one Buyer/Seller Meets in India/Abroad. (d) Arrange Exhibitions in India and Abroad for market promotion. (e) Assist in Regulatory matters with domestic and Foreign Government agencies. (f) Provide financial assistance for Product Registration charges, Research and Development, Product showcasing etc. as per rules. (g) Arrange Conferences/Seminars in domestic and foreign countries - for market and technical up-gradation of information
4.12 SWOT Analysis of Indian Pharma Industry India advantage Cost competitiveness due to lower labour cost and production cost Well-developed industry with strong manufacturing base Well established network of Laboratories and R & D infrastructure for new drug discovery and development Access to pool of highly trained and skilled scientists, both in India and abroad Strong marketing and distribution network in domestic as well as international market India is second largest country in terms of population in world with rich biodiversity Expertise in reverse engineering and development of new Chemical process made Indian pharmaceutical industry as one of the strongest generic industry Weaknesses Low investment in innovative Research & Development Lack of resources to compete with MNCs for New Drug Discovery Research and to commercialise molecules on a worldwide basis Lack of strong linkages between industries and academia Lack of culture of innovation in the industry Low per capita medical expenditure and healthcare spend in country Inadequate regulatory standards Production of spurious and low quality drugs tarnishes the image of industry at home and abroad
Emerging trends and opportunities Significant export potential to the developing as well as developed countries Licensing deals and collaborations with MNCs for New Chemical Entities and New Drug Delivery Systems Providing marketing operations to sell MNC products in domestic market India can be niche player in global pharmaceutical R & D by developing world class infrastructure Contract manufacturing arrangements with MNCs Potential for developing India as a centre for International Clinical Trials Increasing aging world population Increasing incomes and buying power of people especially in rural areas has opened the great opportunity for Indian pharma companies. Around 70% of the total population of India is residing in rural areas. Growing awareness for health and increasing spending on health Threats Product patent regime poses serious challenges to domestic industries unless it invests in R & D. R & D efforts of Indian pharmaceutical companies hampered by lack of enabling regulatory requirement. For instance, restrictions on animal testing out-dated patent office. DPCO puts unrealistic ceilings on product prices and profitability and prevents pharmaceutical companies from generating investible surplus. Exports effort hampered by procedural hurdles in India as well as non-tariff barriers imposed abroad.
4.13 LAWS AND REGULATIONS GOVERNING INDIAN PHARMACEUTICAL The drugs and cosmetics act,1940 This act regulates the import,manufacture,distribution and sale of drugs in india It contains in detail the regulation divided the difference schedules A to Y, schedule I and schedule II. Some very impotents schedules are as follows: Schedule M of the drugs and cosmetics act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs part I describes good manufacturing practices for premises and materials. Part II deals with requirements of equipments. Schedule T of the drugs and cosmetics act prescripts good manufacturing practices specification for manufactures of ayurvedic, siddha and unani medicines. it is divided in two parts. Part I deals with good manufacturing practices ,while part II deals with list of machinery ,equipment and minimum manufacturing premises required for their manufacture. Schedule y of the drugs and cosmetics act specifies about the requirement and guidelines on clinical trials for import and manufacture of new drug. Additionally this act provides for construction and functioning of various regulatory bodies like drug technical advisory board, drug consultative committee, central drugs laboratory etc. The pharmacy act,1948: Indian market is 13 th in domestic consumption value. Such a big market is regulated by This act. This legislation regulates the profession of pharmacy in India. Under the provisions of this act the central government constitutes a central pharmacy council of India and the state governments constitutes a central pharmacy state pharmacy councils. Provisions regarding joint state pharmacy council are also mentioned to the states who agree to share these services jointly. the composition, structures and functions of councils are also described. these councils control provisions regarding registration of pharmacists, education, removal of name from register etc. The drugs and magic remedies (objectionable advertisement) act,1954: An act to control the advertisement if drugs in certain cases, to prohibit the advertisement for certain purpose of remedies alleged to process magic qualities and to provide for matters connected therewith. The narcotic drugs and psychotropic substances act 1985: This is an act to consolidate and amend the law relating to narcotic drugs, to make stringent provisions for the control and regulations of operations relating to narcotic drugs and psychotropic substances and for matters connected therewith. The medicinal and toilet preparations (excise duties) act, 1956: This act lay down the regulations for the levy and collection of duties of excise on medicinal and toilet preparations containing alcohol. it also specifies the manufacturing conditions to be maintained for such products. Good clinical practice (GCP) guidelines: For any type of clinical study involving human volunteers it is mandatory to follow these guidelines. These are draft guideline for research in human subjects. These GCP guiltiness are essentially based on declaration of Helsinki, world health organizations (WHO) guidelines and international conference on harmonization (ICH) requirements for good clinical practice. Good laboratory practice (GLB) guidelines: Good laboratory practice is defined in the OECD principles as a quality system concerned with the organizational process and the conditions under which non-clinical health and environment safety studies are planned, performed , monitored, recorded, archived and reported. The purpose of the principles of good laboratory practice is to promote the development of quality test data and provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving. Indian patent act 1940: The acts started objective was to foster the development of an indigenous Indian pharmaceutical industry and to guarantee that the Indian public had access to low-cost drugs the patent bill was first introduced on parliament in 1967,but the patent act,1970 came into forces only in 1972. The drugs price control order (DPCO), 1995: This is an order issued by the government of India under the essential commodities act,1995 to regulate the prices of drugs. The order provides the list of prices of drugs. The order provides the list of prices controlled drugs, procedures for fixation of prices of drugs, method of implementations of prices fixed by government and penalties for contravention of provisions among other things. The following are some of the other laws which have a bearing on pharmaceutical manufacture, distribution and sale in India: The industries (Development and regulation) act, 1951 The trade and merchandise marks act,1958 The Indian patent and design act. Factories act.
4.12 MINISTRY OF HEALTH & FAMILY WELFARE (DEPARTMENT OF HEALTH): Central drugs standard control organization (CDSCO): As an agency of the department of health, the CDSCO works both at the central and the state level and is responsible for ensuring safety, efficacy and quality of drugs supplied to the public. The agency performs the above mentioned functions with the drugs controller general of India (DCGI) as the executive head. Drugs controller general of India(DCGI): The dcgi is an apex body in the pharmaceutical industry governing issues such as approval/NOC for clinical trials, bioequivalence studies and marketing permission in India. Along with it is also responsible for approval for test license, testing of drugs, registration for import and licensing. Export NOCs=biological samples. Drugs.etc., licensing of blood banks- DNA products. Vaccines and medical device. Amendment in drugs and cosmetics acts and rules from time to time Ministry of chemicals and fertilizers: The ministry of chemicals & constitutes bodies such as the department of chemicals & petrochemicals (DCP) and the national pharmaceutical pricing authority(NPPA). These departments are entrusted with the responsibility of policy making, planning development and regulations relating to chemicals, petrochemicals and pharmaceuticals.
4.16 NEW DRUG REGISTRATION: Medicinal products count as new drugs in India if they fall into one of the following categories: Drugs not previously available in Indian market. Drugs with new therapeutic indications or dosages that have not been marketed in India. New fixed-dose combinations of two or more drugs. Any drug which was first approved in India less than four years ago, unless it is included in the Indian pharmacopoeia. All vaccines are treated as new drugs, unless notified otherwise by the DCGI.
For permission to import or manufacture of new drug substance and its formulation for making in the country, applicant required to fill application in form 44 along with prescribed fees in the form of treasury challan and all relevant data as per schedule Y to Drug and cosmetics rules which include chemical & pharmaceutical information. Animal pharmacological & toxicological data, clinical data of safety and efficacy regulatory status in other countries etc and results of clinical trial on local population. New drug time frame in which the application has to be reviewed, but a typical range is around 12-18 months.