To ensure credibility and authenticity of the alternative traditional medicines in view of their increasing demand in domestic and foreign market, the Union Ayush Ministry has asked the States to strictly follow regulatory norms such as taking stringent action in the cases where the drug sample has been found to be substandard, spurious, misbranded or adulterated.
The instructions came after the Ministry in a recent training session with the State Government found that various regulatory and enforcement mechanisms were not being enforced to the desired extent while quality control of the alternate traditional drugs and their advertisements were inadequate.
Accordingly, said a senior official from the Ministry, the States have been asked to appoint state licensing authority, drug inspectors and government analyst for Ayurvedic, Siddha and Unani drugs. “Non-technical officer cannot be appointed as licensing authority for the Ayush drugs,” the official made it clear.
Similarly, the States have been asked that manufacturing license for the traditional drugs may not be granted or renewed without GMP (good manufacturing compliance) by the manufacturer.
“licenses of manufacturing units not complying with the GMP provisions need to be revoked or cancelled with immediate effect. licensing authority may grant or renew the license only on being satisfied that references of the ingredients and formulations of ASU drugs are from the authoritative books listed in the Drugs & Cosmetics Act and quality standards and proof of safety & effectiveness of the intended drugs are in accordance with the pharmacopoeia.
Also, the States have been asked that a properly functional drug testing laboratory with required infrastructural facilities and technical manpower may be set up and Government analyst be notified to supervise the testing of drugs and sign the test reports.
“Proper quality control must be ensured for the ASU&H drugs being manufactured, marketed, supplied to the dispensaries & hospitals and distributed to the public.
“In this regard, State regulatory officers should pick up adequate number of drug samples for testing of their quality in a recognised laboratory and take appropriate action in accordance with the relevant provisions of Drugs & Cosmetics Act and Rules, if the test report is not satisfactory and the drug sample has been found to be substandard, spurious, misbranded or adulterated. legal or administrative action may be initiated against the defaulters and offenders as per the rules.”