Quality Control of Ayush Drugs

By PIB Delhi

As prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha, Unani and Homoeopathic drugs, is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani medicines and Rule 85 (A to I)in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Homoeopathic medicines. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-Iof Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate office under Ministry of Ayush lays down Pharmacopocial Standards and Formulary specifications for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs within the ambit of Drugs & Cosmetics Act, 1940, which serve as official compendia for ascertaining the quality of the drugs included therein.          Further, PCIM&H as an appellate drug testing laboratory receives the samples from Government agencies as per Drugs & Cosmetics Act & Rules there under for ascertaining their quality.           

Details of the number of AYUSH drug and product samples tested by PCIM&H is as follows –

S. No.	Name of the State/UT	Year-wise no. of samples  of ASU&H tested by PCIM&H
2017-2018	2018-19	2019-20	2020-21	2021-22	April 2022 to 13.07.2022
	Bihar	03	–	01	03	–	–
	Delhi	211	466	252	51	319	08
	Gujarat	02		–	–	–	–
	Karnataka	46	09	20	–	–	–
	Maharashtra	66	26	04	10	03	20
	Odisha	58	69	43	09	220	12
	Punjab (Chandigarh)	04	–	79	–	–	62
	Rajasthan	88	–		–	–	76
	Uttar Pradesh	05	05	02	–	01	–
	Uttrakhand	03	08	37	08	132	06
	West Bengal	39		02	01	18	05
	Arunachal Pradesh	–	04	–	03	–	–
	Goa	–	02	06	–	–	–
	Jharkhand	–	36	22	58	14	02
	Rajasthan	–	71	132	143	287	–
	Tripura	–	45	–	–	02	–
	Kerala	–	–	03	–	–	01
	Madhya Pradesh	–	–	01	–	–	–
	Manipur	–	–	39	39	–	–
	Andaman & Nicobar	–	–	–	–	05	–
Total	525	741	643	324	1008	192

    As per the information received from State/ UT Governments, list of Ayush drug and product samples tested in the last five is as follows –

S.no.	Name of the State/UT	Information received from State/ UT Governments regarding  Ayush drug samples tested in the last five
2017-18	2018-19	2019-20	2020-21	2021-22	2022-till date
	Manipur	NIL	NIL	38	16	33	–
	Chhattisgarh	333	693	511	376	566	–
	Goa	10	01	07	29	75	54
	Odisha	967	451	2506	1969	2672	–
	Himachal Pradesh	590	38	462	404	443	–
	Arunachal Pradesh	155	145	161	172	96	–
	Tamil Nadu	1754	1104	3448	1725	1746	–
	Kerala	483	938	719	308	244	–
	Andhra Pradesh	101	07	16	164	25	–
	Karnataka	1014	882	1706	1259	416	–
	Andaman & Nicobar	NIL	NIL	NIL	NIL	10
	Gujarat	302	304	97	408	71	–
	Maharashtra	259	443	406	167	458	115(from 01.04.2022 to 30.06.2022)
	Madhya Pradesh	290	265	05	521	353	482
	Uttar Pradesh	0	09	37	54	89	–
	Puducherry	NIL

Under Centrally Sponsored Scheme of National Ayush Mission (NAM) as per the proposals received from State/UT Governments through their State Annual Action Plans, an amount of Rs. 10723.14 Lakhs has been approved under the component of quality control of Ayurveda, Siddha, Unani & Homeopathy drugs (ASU&H drugs) for different activities including quality testing of drugs from the year 2014-15 to 2019-20.

Ministry of Ayush has implemented Central Sector Scheme AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY). The objectives of the Scheme are as under;

i. To enhance India’s manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat.

ii. To facilitate adequate infrastructural & technological upgradation and institutional activities in public and private sector for standardization, quality manufacturing and analytical testing of Ayush drugs & materials.

 iii. To strengthen regulatory frameworks at Central and State level for effective quality control, safety monitoring and surveillance of misleading advertisements of Ayush drugs.

iv. To encourage building up synergies, collaborations and convergent approaches for promoting standards and quality of Ayush drugs & materials.

The components of the AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) Scheme are as under;

A. Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.

B. Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements.

C. Strengthening of Central and State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush drugs.

D. Support for development of standards and accreditation/ certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Control of India (QCI) and other relevant scientific institutions and industrial R&D centres.   

AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) was approved by Standing Finance Committee (SFC) on 16.03.2021. The total financial allocation to this scheme is Rs 122.00 crores for five years.       

This information was given by Minister of Ayush Shri Sarbananda Sonowal in a written reply in Rajya Sabha today.