As per the Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945, enforcement of the legal provisions pertaining to quality control, safety and issuance of drug license of Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs is vested with the State Drug Controllers/ State Licensing Authorities (SLAs) appointed by the concerned State/ Union Territory Government. Routine inspections and lifting of survey samples are undertaken as part of regular enforcement activities to improve the quality and safety of Ayush medicines/products by Drug Inspectors (Ayush).
As per the information received from the State/UT Governments, details of the number of medicines tested are at Annexure-I.
Further, as per the information received from the State/UT Governments, details of the test results obtained and details of sub-standard or adulterated Ayush medicines reported during this period, including the action taken against manufacturers or distributors are at Annexure-II.
Ministry of Ayush, Government of India has established Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) as its subordinate office. PCIM&H lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs which serves as official compendia for ascertaining the quality (identity, purity and strength) of the ASU&H drugs. As per the Drugs & Cosmetics Act, 1940 and rules thereunder, the compliance to these quality standards are mandatory for the production of ASU&H drugs being manufactured in India. So far, 2269 quality standards on raw materials (single drugs of plant/ animal/ mineral/ metal/ chemical origin) used in ASU&H drugs, 426 quality standards of ASU formulations and 2799 formulary specifications of ASU drugs have been published. In addition to above, supporting documents in the form of Macro-Microscopic & Thin Layer Chromatography (TLC) Atlas on 392 single drugs incorporated in Ayurvedic Pharmacopoeia of India (API) have also been published.
PCIM&H also acts as the Appellate Drugs Testing Laboratory for testing or analysis of ASU&H drugs. In addition, it conducts capacity-building trainings at regular intervals for the standardization, quality control, and testing or analysis of ASU&H drugs for Drug Regulatory Authorities, Drug Analysts, and other relevant stakeholders, with a focus on laboratory techniques and methodologies essential for ensuring the quality of ASU&H drugs.
Further, 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 Good Manufacturing Practices (GMP) as per Schedule T and Schedule M1 of the Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia. As on date, there are 34 State Drug Testing Laboratories and 108 private Drug Testing Laboratories approved or licensed under Rule 160 A to J of the Drugs Rules, 1945, for quality testing of ASU drugs and raw materials. Provisions related to labelling of Ayurveda, Siddha, Sowa Rigpa and Unani drugs are prescribed under Rule 161 of the Drugs Rules, 1945.
The quality of medicinal plants is ensured by promoting Good Agricultural and Collection Practices (GACP). Digital supply-chain tracking system is also available for raw material sourcing and authentication.
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Annexure- I
As per the information received from the State/UT Governments, details of the number of
medicines tested in the past three years are as follows:-
|
S. No.
|
Name of the State/UT
|
Number of medicines tested in the past 03 years
|
|
1.
|
Madhya Pradesh
|
2038
|
|
2.
|
Delhi
|
1606
|
|
3.
|
Tripura
|
259
|
|
4.
|
Gujarat
|
533
|
|
5.
|
Goa
|
519
|
|
6.
|
Kerala
|
1534
|
|
7.
|
Chandigarh
|
13
|
|
8.
|
Mizoram
|
426
|
|
9.
|
Uttarakhand
|
503
|
|
10.
|
Arunachal Pradesh
|
NIL
|
|
11.
|
Ladakh
|
NIL
|
|
12.
|
Lakshadweep
|
NIL
|
Annexure- II
As per the information received from the State/UT Governments, details of the test results obtained and details of sub-standard or adulterated Ayush medicines reported during past three years, including the action taken against manufacturers or distributors are as follows:
|
S. No.
|
Name of the State/UT
|
Number of samples failed/found Not of Standard Quality (NSQ)/Action taken thereon during the past 03 years
|
|
1.
|
Madhya Pradesh
|
335
|
|
2.
|
Delhi
|
07
|
|
3.
|
Tripura
|
43
|
|
4.
|
Gujarat
|
55
|
|
5.
|
Goa
|
01
|
|
6.
|
Kerala
|
62
|
|
7.
|
Maharashtra
|
56
|
|
8.
|
Mizoram
|
18
|
|
9.
|
Uttarakhand
|
132
|
|
10.
|
Nagaland
|
01
|
|
11.
|
Chandigarh
|
NIL
|
|
12.
|
Arunachal Pradesh
|
NIL
|
|
13.
|
Ladakh
|
NIL
|
|
14.
|
Lakshadweep
|
NIL
|
This information was given by the Minister of State (IC) for Ayush Shri Pratap Rao Jadhav in a written reply to a question in Rajya Sabha today.
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SR/GS/SG