Proposed Drugs Act: Govt panel mulls removing penal provisions for lapses

New Delhi: In the process of designing new legislation for drugs, cosmetics, and medical devices to replace the present Drugs and Cosmetics Act, which was enacted in 1940, the high-level government committee is going to consider decriminalising offences and intending to exclude penal elements in the case of a quality-related failure from the proposed Drugs and Cosmetics Act.

This came in line with the meeting earlier this month between the expert panel and concerned stakeholders, at which industry experts urged that criminal measures be removed from the draft copy of drugs and cosmetics Act in the scenario of a quality-related failure, as they led to harassment.

The Medical Dialogues Team had earlier reported that the Central government had constituted an eight-member expert committee chaired by the Drugs Controller General of India (DCGI), Dr V.G. Somani, to draft new legislation for drugs, cosmetics, and medical devices to replace the present Drugs and Cosmetics Act, which was enacted in 1940.

The eight-member panel will review the 1940 Drugs and Cosmetics Act and suggest new legislation to regulate drugs, cosmetics, and medical devices in the country. As per various media reports, the committee is expected to submit a draft document by November 30.

Any drug or cosmetic deemed to be adulterated or spurious is punishable by imprisonment and a fine under the current Drugs and Cosmetics Act.

According to a recent Economic Times report, sources told that the committee is considering eliminating criminal rules if a drug or medical equipment has not injured a patient. Further, it is expected that in such circumstances, the manufacturer may be subjected to a "financial penalty."

In connection with the above, earlier this month, a meeting was held between the expert panel and concerning stakeholders. Pharma lobby groups such as the Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers' Association, Federation of Pharmaceutical Entrepreneurs, Bulk Drug Manufacturers Association, and other industry associations were among those present at the meeting.

Sources told ET, industry experts recommended doing away with the penal provisions, and the expert panel has agreed to it in-principle.

Furthermore, industry experts suggested that criminal provisions be eliminated as they led to harassment.

Citing the existing penal as "unnecessary criminal provisions", Sudarshan Jain, the secretary-general of the IPA, which represents 20 of the country's largest drug companies, said a revamp is necessary and the existing penal should be updated.

He further added, "We have recommended financial penalties instead of criminal penalties like imprisonment at least till guilt is proven. At present, the practise is that the manufacturer can be imprisoned even before the investigation is concluded. The existing Act needs modification, "