NEW DELHI:
An in-depth review by the Ayush ministry has revealed many chinks in the regulatory armour of states and union territories that could seriously undermine the quality and efficacy of Ayurvedic, Siddha, Unani and homeopathic (ASU&H) drugs sold in the country. The ministry, it is learnt, is adopting rigorous measures to plug gaps in the legal framework and plans are afoot to hike headcount of state drug inspectors and insist on appropriate technical qualifications for licensing authorities.
The review has shown that the provisions of the Drugs and Cosmetics (D&C) Rules of 1945, Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954 and various orders and directives issued by the Central government are not being enforced. Quality control measures of ASU&H drugs were also found to be missing the mark and manufacturers are often allowed to advertise products without necessary checks and balances.
According to official sources, the ministry’s Drug Control Cell last week formulated an action plan to boost regulatory enforcement following the review and issued directives to state Ayush officials concerned. The review was conducted on the basis of data obtained from a series of workshops on regulations conducted from January to March this year in New Delhi, Chennai, Shillong, Pune, Chandigarh and Bhubaneswar. Representative regulatory officers, licensing authorities, manufacturers and scientific personnel from ASU pharmacies and drug testing labs participated in the training programme.
The ministry has noted that the state licensing authority, drug inspectors and government analyst for ASU drugs are often not appointed in accordance with the qualifications prescribed in the D&C Rules. It has now directed the state authorities not to appoint non-technical officers as licensing authority.
The state governments are also directed to appoint at least one Ayush drug inspector for every 30 manufacturing units. The appointment of other drug control officers should be done on the basis of workload and area of jurisdiction.
Besides, the ministry charted a detailed course of action to boost drug quality. Henceforth, licence for Ayush drug production won’t be granted without good manufacturing practice (GMP) compliance by the manufacturer and units that fail to comply with the provisions will have their licences cancelled or revoked. The licensing authority should keep an eye on drug ingredients and design of the drug label should be as per the provisions of Rule 161 of D&C Rules. A well-equipped drug testing laboratory should be established by all states and the government analyst should supervise and sign test reports.
A gazzetted officer should be appointed by all states and UTs to monitor Ayush drug advertisements under Section 8 (1) of the Drugs and Magic Remedies Act and a web-portal to upload information on regulations and licensed manufacturers should be maintained.
While the findings of the latest review would be a matter of concern for the industry and the consumer, researchers in alternative medical fields point finger at the Central government for watering down drug safety norms on a regular basis. For instance, a recent directive by the ministry directed all state drug regulators to issue licences for patented or proprietary ASU medications without insisting on clinical trial or safety study reports. Many Ayush practitioners pointed out that the move would seriously harm the credibility of these systems of medicine and help fraudsters flourish.
The decision was detrimental to the efforts of many states to weed out ineffective and potentially harmful drugs from the market. The circular also took away state governments’ authority to designate, authorise or notify a particular institution for conducting pilot studies on ASU drugs. According to researchers, this clause will go against all attempts to meaningfully integrate ASU and modern systems of medicine.
