Major pharma industry associations have called a meeting on April 29 at IDMA office in Mumbai to discuss the issue of preparing guidelines to help the drug inspectors while implementing the provisions of the recently amended Drugs & Cosmetics Act. The meeting comes in the wake of DCGI's directive to the industry to submit a guideline/manual to ensure fair and transparent implementation of the Act which stipulates stringent punishment for manufacturing and selling of spurious drugs.
Apart from representatives from prominent industry associations like IDMA, IPA, OPPI, etc, the meeting will be attended by industry and regulatory experts like S W Deshpande, Manoj Tongra, Dr Milind Joshi, S M Mudda, Dr R Rajan and Vinod Kalani.
Ever since the government introduced the Drugs and Cosmetics (Amendment) Bill 2008 in Parliament last year, the industry has been expressing its concern on the implementation of the Act. But the industry has itself to blame for the goof up in the entire matter as it responded to the Bill at the eleventh hour only when the Bill was on the verge of its passage in Parliament. The Bill was passed by Parliament in a hurried manner and it received president's nod in December last year.
A bewildered industry did not abandon its efforts to rectify the Bill as certain provisions in this Act will have far-reaching consequences on the genuine manufacturers. The industry knocked at the doors of senior health ministry officials to address the concerns of the genuine manufacturers. The officials responded positively to the industry and decided to come out with guidelines to address the concerns and constituted a sub-committee on the issue.
After preparing a common guideline, the industry will submit it to the DCGI.
While the industry has appreciated the intention of bringing the Bill, it is apprehensive of certain provisions which may be misinterpreted and even the genuine manufacturers may end up in jails for no faults of theirs.
Since there is no mention of definition on substandard drugs in the Bill, if any drug is found substandard the manufacturer will be charged for manufacturing and selling of adulterated or spurious drugs.
There is also apprehension among the industry on misuse of the provisions of the Act by the drug inspectors as the Act gives sweeping powers to the drug inspectors and the police to initiate action against the erring drug manufacturers and marketers. The meeting will discuss all these issues and come out with a common approach to address the concerns of the genuine manufacturers.