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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.
