Strengthening of Quality Control System in the

States/UTs for Ayurvedic, Siddha, Unani and

Homoeopathy (ASU&H) Drugs

Dr D.C. Katoch
Adviser (Ay.) & Head- Drug Control
Ministry of AYUSH, Govt. of India
 Functionaries dealing with ASU&H drugs

Registered Practitioners 7,73,668*

Total Teaching Institutions (ASU&H): (A-281, U-44, S-9, H- 197) 622

Postgraduate Institutions (ASU&H): (A-112, U-9, S-3, H-43) 201 +9

Annual Intake in Degree courses: (A-15117, U-2131, S- 410, H-13658) 33,601

Annual Intake in PG courses: (A-3089, U-147, S-140, H-918) 4,876

Hospitals in Government Sector 3,943

Dispensaries in Government Sector 27, 698

Drug Manufacturing units (A-7439, U- 585, S-235, H-408) 9038

*Coverage: About 6 AYUSH practitioners per 10,000 population . 2

 Integrated or Co-located AYUSH Functionaries

• AYUSH services available in-

506 out of 697 District Hospitals,
374 out of 2725 Sub-district Hospitals,
2871 out of 11225 Community Health Centres,
8995 out of 31849 Primary Health Centres
5716 other healthcare centres.

• 15649 AYUSH practitioners appointed for

National Child Health Program and 12263 for
imparting general health services.
 Need for Regulatory Provisions &
Quality Control System
• To prescribe and enforce standards for
manufacturing, distribution, sale and
dissemination of information of drugs.

• To ensure availability of standard drugs

( quality, safety, efficacy) to the people.

• To promote public protection from

hazards/harmful effects of drugs.
 Legal Provisions /Regulations for ASU &H drugs
• Drugs and Cosmetics Act, 1940
– Section 3(a) & (h), Chapter IVA from Section 33B to 33O and First
Schedule pertain to ASU drugs.

– Second Schedule (4A) provides for quality standards of Homoeopathic

drugs.

• Drugs and Cosmetics Rules, 1945

– Rules 151 to 170, Schedules E(I) for poisonous substances, T for GMP
and TA for consumption data of raw materials pertain to ASU drugs.

– Rules 30AA, 67, 85 (A to I), 106-A, Schedule K, Schedule M-I pertain

to Homoeopathic drugs.

• Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and

Rules
• Principal Act meant for prohibiting advertisement of all kinds of drugs
for certain diseases/conditions and improper claims.
 Types of Legal Provisions
• Enabling provisions
• Prohibitive provisions
• Penal provisions
• Empowering provisions for Government
authorities and for taking specific actions
• Exemption provisions
 ASU drugs related provisions of Chapter IVA
• ASUDTAB and ADUDCC- Advisory bodies to Central and State
Governments.
• Misbranded, Spurious and Adulterated drugs
• Standards of ASU drugs
• Prohibition of manufacturing and sale of ASU drugs by State Government.
• Prohibition of manufacturing, sale etc of ASU drugs by Central
Government.
• Appointment of Government Analysts, Inspectors
• Penalties
• Confiscation of the stock of ASU drugs
• Disclosure of ASU drug information to the Inspector
• Maintenance of records and furnishing of information by license holder
• Cognizance of offences
• Rules making power of the Central Government
• Powers of Central Government to amend First Schedule
Powers of Central Government to give directions to State Governments
 Nature of ASU Drugs
• Made from wholesome natural substances of plant, animal,
mineral or marine origin.

• Formulation may be of single ingredient or multiple

ingredients or combination of different formulations.

• Formulation could be herbal, herbo-mineral or any kind of

mixture of two or more natural substances.

• Wholesome extract of medicinal plant (aqueous extract or

hydro-alcoholic extract or any other extract) can be the
ingredient of ASU formulations.
 Broad Types of ASU Drugs
• Classical/Shastriye/Traditional: Ayurvedic, Siddha
or Unani drug includes all medicines intended for internal or
external use for or in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human beings or animals,
and manufactured exclusively in accordance with the
formulae described in the authoritative books of Ayurvedic,
Siddha and Unani Tibb systems of medicine, specified in the
Schedule I of the Act.

i.e such formulations as are described in 103 authoritative

books including pharmacopoeias and formularies.
Contd…
• Patent or Proprietary: ASU formulations
containing only such ingredients, which are
mentioned in the formulae described in the
authoritative books and do not include a
medicine for parenteral administration and
the formulation mentioned in any of the
authoritative books.

i.e. only ingredients/natural substances mentioned in the

authoritative books can be used for manufacturing of
patent/proprietary ASU medicines.
Phytopharmaceuticals are not ASU Drugs

Phytocpharmaceutical drug means and

includes purified and standardized fraction with
defined minimum four bio-active or phytochemical
compounds (qualitatively and quantitatively
assessed) of an extract of a medicinal plant or its
part, for internal or external use of human beings
or animals for diagnosis, treatment, mitigation or
prevention of any disease or disorder but does not
include administration by parenteral route.
Sub-Types of Proprietary ASU Formulations

Cosmaceutical
Medicinal Nutritive Formulation
Formulation
Formulation (Balya, Poshak)
(Saundaryaprasadak)

Aqueous or Hydro Other Extract-based

alcoholic Extract Formulation
based Formulation
Essentials for Manufacturing of ASU &H drugs

1.
License for the
manufacturing 2.
unit and
regulatory GMP Compliance
approval of
intended
formulations

3.
4.
Adequate
Compliance to infrastructural
prescribed facility, staff,
Standards, equipment,
Norms, Guidelines reference books ,
and quality reference
assurance standards record
keeping etc.
 License requirements for Classical/Shastriye
Formulations

1. Shastriye ASU formulation with • Safety study not required

dosage form and indications as per • Evidence of effectiveness from
authoritative text authoritative source required.

2. Shastriye ASU formulation with • Safety study not required

change in dosage form • Evidence of effectiveness from published
literature required.

3. Shastriye ASU formulation with new • Safety study not required

indication • Evidence from published literature and/or
proof of effectiveness required.
 License Requirements for Proprietary
Formulations
1. Proprietary formulation with • Safety study not required
ingredients not from Schedule E(I) and • Evidence of effectiveness of
based on textual rationale from ingredients from published literature
authoritative books. required.
• Proof of effectiveness from a pilot
study required.

2. Proprietary formulation with any of the • Safety study required

ingredients from Schedule E(I) and based • Evidence of effectiveness from
on textual rationale from authoritative published literature and proof from
books. pilot study required.
 License Requirements for Extract-based
Formulations
1. Aqueous extract as per text • References from the authoritative texts required

2. Aqueous extract as per text • Safety study not required

but with new indication • Proof of effectiveness required

3. Hydro-alcoholic extract as per • Evidence of effectiveness may be required on case

text to case basis.

4. Specific Hydro-alcoholic extract • Safety study required

with New Indication • Evidence and proof of effectiveness required

5. Other extracts made from • Acute and Chronic Toxicity, Mutagenicity and
various solvents. Teratogenicity data required.

• Evidence of effectiveness from published literature

and proof from clinical study required.
 Regulatory Framework
Central Govt. State Govt. Statutory bodies
• Makes and amends • Responsible to enforce the • ASUDCC to advise Central &
regulatory provisions. legal provisions for ASU&H State Governments for
drugs and related matters. uniform implementation of
• Has the powers to give the Act.
direction to the States in • Appointment of Licensing
respect of achieving Authority/Drug Controller, • ASUDTAB to advise Central
objectives of the Drugs & Drug Inspectors & State Governments for
Cosmetics Act. technical/policy matters of
• Drug Testing Laboratory ASU drugs
• Pharmacopoeia Commission
of Indian Medicine & • Sub-committee of
Homoeopathy and • Appointment of Govt.
Analyst. Homoeopathy and DTAB.
Pharmacopoeia Committees.

• Central Laboratories – PLIM

and HPL with Govt. Analysts.
 Requirements for making License Application
• Reference of the formulation/ingredients from the
authoritative books listed in the Drugs & Cosmetics Act,
1940.

• Manufacturing unit should be compliant with the GMP

guidelines as prescribed in Schedule ‘T’ of the Drugs &
Cosmetics Rules, 1945.

• Proof of safety and effectiveness as prescribed in Rule

158-B for various categories of ASU medicines.
 Contd…..
• Standards of identity, purity and strength and permissible limits of heavy
metals, aflatoxins, microbial load and pesticide residue of medicinal plant
materials prescribed in the respective Pharmacopeias.

• Standardized classical formulations prescribed in National Formularies.

• Label of the drug must contain true list of ingredients (with plant part and
form), manufacturing and expiry dates and caution in case of presence of any
of Schedule E(I) ingredients in the formulation.

• Test report/Certificate of Analysis of not more than 12% v/v self generated
alcohol in Asavas & Arishtas.

• In-house standards and testing protocols for proprietary medicines.

Standards of Identity – Purity-Strength of ASU& H Drugs

Ayurvedic Unani Siddha

Pharmacopoeia Pharmacopoeia Pharmacopoeia

645 (9) 298 monographs 139 monographs

monographs of of
of Single Drugs Single Drugs
Single Drugs

150
202 (4) monographs of Homoeopathic
monographs of compound Pharmacopoeia–
compound formulations 1117 monographs
formulations
 Standard ASU Formulations

Ayurvedic National Siddha

Formulary of Formulary of Formulary of
India Unani Medicine India

985 (3 volumes)
including 280 1229 399 (2 volumes)
mineral-based (6 volumes)
formulations
 Quality Certification Systems

• GMP certification must.

• Free Sale Certificate and Non-conviction Certificate on demand.

• WHO-GMP/COPP certification for export-oriented ASU herbal drugs.

• Voluntary certification of quality of AYUSH products through Quality Council of India (QCI)
scheme.

– Ayush Standard Mark: based on compliance to the standards more than the domestic
regulatory requirements.

– Ayush Premium Mark: broadly based on compliance to WHO-GMP/USFDA criteria or

GMP prescribed by importing country or fulfillment of quality requirements as per
international norms.
 Responsibilities of State Regulator/ Licensing Authority
• To ensure that manufacturing site has all required clearances and approvals and adequate
manufacturing facilities.

• To ensure whether the manufacturing premises are complying with the GMP norms.

• To consider whether the documents submitted with license application are complete and the conditions
laid down in Drugs & Cosmetics Rules, 1945 are fulfilled to grant or renew the license.

• To consider correctness of the contents on the label of medicines in accordance with labeling provisions.

• To undertake quality check of adequate number of ASU & H drug samples taken from manufacturing
sites and market.

• To monitor advertisements of ASU&H drugs appearing in print and electronic media for misleading
claims.

• To maintain the record of licensed manufacturers, approved medicinal products, raw materials
consumption data and upload the details in the website.

• To take regulatory action against defaulters acting in contravention of the provisions of Drugs &
Cosmetics Act and Drugs & Magic Remedies Act and rules thereunder.
Outcome Analysis of Quality Control of ASU&H drugs in last four years of
NAM Implementation
 28 State Drug Testing Laboratories and 32 State Pharmacies supported for improving their
infrastructural and functional capacities. But the functional status is doubtful.

 Support provided to 31 states for testing of ASU&H drugs and strengthening of enforcement
framework but lack of scientific manpower in the DTLs and weak regulatory mechanism
continues

 Enforcement of legal provisions resulted in improved compliance to Good Manufacturing

Practices (GMP) from 82.9% in 2014 to 85.8% in 2018, still licenses to manufacturing units are
issued and renewed without GMP compliance.

 Efforts for effective control of misleading advertisements and Quality testing of drug samples
need to be enhanced and action taken against the defaulters.

 23 states reported to have appointed gazetted officers for monitoring of misleading

advertisements of ASU&H drugs but their performance is not visible /reported.

 Grant funds are lying unutilized or not fully utilised and UCs not submitted /settled as per GFRs.
New initiatives for strengthening quality control of ASU&H drugs

1. Central AYUSH Vertical structure created in CDSCO in February, 2018 with 12 posts
of Drug Inspectors, Assistant Drug Controllers and Deputy Drug Controllers.

2. Scheme of Pharmacovigilance for safety monitoring of ASU&H drugs and

surveillance of misleading advertisements implemented since November, 2017.

3. e-aushadhi Portal for online Licensing/Certification etc. of ASU&H drugs has been
developed and launched for trial and to get feedback from the states.

4. Rule 170 for prohibition of misleading advertisements of ASU drugs notified on 21st
December, 2018 under Drugs & Cosmetics Rules, 1945.

5. Order for the Expert Committee in the State for examination of license applications
of ASU formulations has been revised with specific ToRs and issued on 4h February,
2019.
 Issues and concerns in the States about Quality
Control of ASU&H drugs
a) State Licensing Authority for ASU drugs must be a technical officer as
per Rule 162-A of D&C Rules.

b) One drug inspector per 30 manufacturing units may be appointed.

Adequate number of Drug Inspectors required in following States:
State Total no. of Existing number Additional Drug
Manufacturing of Drug Inspectors inspectors
units* required

Andhra 2 9
Pradesh 326
Bihar 286 0 10
D&N Haveli 5 0 1
Daman & Diu 9 0 1
Sl. No State No. of Existing Additional drug
Manufacturing number of inspectors
units* Drug required
Inspectors

5 Jharkhand 34 0 1
6 Karnataka 236 6 2
7 Kerala 753 8 17
8 Odisha 99 1 2
9 Puduchery 37 1 1
10 Rajasthan 317 4 7
11 Telangana 632 4 17
12 West 3 8
Bengal 316
* As on 1-4-2017(Source AYUSH in India 2017)
 Contd….
c) As per D&C Rules, 1945 GMP compliance is mandatory for
manufacturing of ASU&H drugs. Following states are required to take
urgent action for ensuring that licenses are not granted or renewed
without GMP Compliance.

S. State / UT Total GMP Non-Compliant

No. Units* units*

1 Maharashtra 834 391

2 Uttar Pradesh 1835 266
3 Gujarat 581 162
4 Bihar 286 143
5 West Bengal 316 88
6 Assam 44 36
Contd.

S.no. State / UT Total GMP Non-

Units* Compliant units*
7 Puducherry 37 35
8 Jharkhand 34 34
9 Odisha 99 23
10 Telangana 632 20
11 Rajasthan 317 16
12 Jammu & Kashmir 22 10
13 Karnataka 236 7
* As on 1-4-2017 (Source AYUSH in India 2017)
Contd….
d) Actions may be taken to ensure that each State Drug Testing
Laboratory (DTL) supported through NAM and erstwhile Centrally
Sponsored Scheme -
i) is properly equipped with necessary infrastructure & technical
manpower, made functional and is approved/licensed under Drugs &
Cosmetics Rules, 1945 ( Rule 160 A to J).
ii) Govt Analyst has been appointed and notified
iii) Regular testing of sufficient number of ASU&H drug samples
(taken from market, manufacturing units, Govt supplies, complaints is
done and findings are reported to the State and Central
Governments and action is initiated against the failed samples.
iv) Financial support required for the DTL be clearly reflected in the
State Annual Action Plan with necessary details and justification.
 Contd…
e) State Pharmacies supported through NAM and earlier through the
Centrally Sponsored Scheme should be-

i) properly equipped with required infrastructural facilities and

manpower;

ii) GMP compliant and licensed under Drugs & Cosmetics Rules, 1945;

iii) Capable to manufacture and supply sufficient quantity of quality

medicines to State Government dispensaries, hospitals and other health
facilities;

iv) Financial support required for strengthening may be reflected in SAAP

with necessary details and justification in accordance with NAM
guidelines.
 Contd….
f) Misleading advertisements with improper contents and exaggerated
claims of ASU&H drugs in print and electronic media need to be
controlled by enforcing the provisions of Drugs & Magic Remedies
(Objectionable Advertisements) Act, 1954 and Rules thereunder and
recently notified Rule 170 of the Drugs & Cosmetics Rules, 1945.
i) Necessary legal action should be initiated immediately against the alleged
advertisement on receiving information from the reporting
officer/inspector of the State and the complaints escalated from
Consumers, GAMA Portal of Department of Consumer Affairs, Advertising
Standards Council of India (ASCI), Ministry of AYUSH and
Pharmacovigilance Centres and through RTI Applications and Public
Grievances. FIR can be filed with the Police in case details of the
manufacturer or advertiser are not known and authority of concerned state
can be approached.
Contd….

ii) Regulatory officers in the states must undertake regular surveillance

of misleading advertisements in the print and electronic media.

iii) List of defaulters, faulty advertisements and action taken against

them may be put in the website for protecting public from the use of
such medicinal products and also reported to Central Government
periodically and as & when asked for.

iv) Misleading advertisements of ASU&H drugs manufactured in other

state must be reported to the Licensing Authority of that state.
g) Settlement of long pending Utilization Certificates under the
erstwhile Centrally Sponsored Scheme of
Quality Control of ASU&H Drugs.

Action required from following states:

S. State/UT Amount of UC pending (Rs. in
No. lakhs) and Since
1 Assam 25.72 (2003-04)
2 Bihar 243.54 (2000-01)
3 Himachal Pradesh 86.80 (2002-03)
4 Jharkhand 258.06 (2005-06)
5 Madhya Pradesh 100.00 (2011-12)
6 Maharashtra 9.52 (2003-04)
S.No State/UT Amount of UC pending (Rs. in lakhs)
and Since
7 Meghalaya 25.85 (2003-04)
8 Orissa 87.11 (2004-05)
9 Sikkim 134.89 (2006-07)
( Achievement cum Performance report, Register of
Assets and Certificate of not availing any other grant for
the same purpose are not provided with the recently
submitted UCs)

10 Tamil Nadu 136.00 (2007-08)

11 Tripura 78.71 (2003-04)
12 Uttar Pradesh 226.18 (2000-01)
13 Uttarakhand 21.56 (2004-05)
14 Lakshadweep 16.00 (2007-08)
 Revised Funding Pattern of NAM for Drugs Quality Control Activities
Intended Existing Pattern Proposed revision
Activity

Overall No fixed norm 10% of the state envelop

share for
Drugs Note: States/UTs may explore the possibility of
Quality establishing and maintaining pharmacy & DTL as
Control joint asset by pooling resources and for effective
management of supply and quality testing of
medicines.
Pharmacy Maximum Rs 5.00 cr Non Recurring: Rs. 3.50 cr for construction and Rs.
(70% i.e. Rs. 3.50 cr for 2.50 cr for equipment/instruments in two installments
building & equipment minus amount of grant already under NAM.
and 30% i.e Rs. 1.50 cr Recurring: Rs 25 lakhs per year
for recurring
expenditure on
manpower, raw
materials etc.
DTL Maximum Rs 4.00 cr Non Recurring: Rs. 3.00 cr for construction and Rs.
(80% i.e. Rs. 3.20 cr for 2.00 cr for equipment/instruments in two installments
building & equipment minus amount of grant already under NAM.
and 20% i.e Rs. 1.20 cr Recurring: Up to Rs 25 lakhs per year
for recurring
expenditure on technical
manpower, chemicals &
 Contd…..
Capacity building for Up to Rs 25.00 lakh per year
enforcement of ----- for quality control training
regulatory provisions workshop, computerization,
& quality control data management,
infrastructure strengthening
etc of regulatory framework .
Strengthening of Upto Rs 50.00 lakh including --
Drugs Control Rs. 20.00 lakh as first installment
framework and Rs. 30 .00 lakh in subsequent
installments
Documentation etc of Upto Rs. 8.00 lakh per annum ---
quality control
materials

Testing of drugs Rs. 15.00 lakh per year for large ---
states and Rs. 5.00 lakh per year for
UTs & NE states except Assam.
 Thanks
*For any regulatory/enforcement query, clarification or guidance,
write to-

dcc-ayush@nic.in , dc.katoch@gov.in

Drug Control Cell

Ministry of AYUSH
AYUSH Bhawan, ‘B’ Block, GPO Complex
INA, New Delhi-110023.