India to frame new laws for drugs, government forms panel

The Indian government has set up a panel to frame new laws for drugs, cosmetics and medical devices. The newly formed eight-member panel is to be headed by VG Somani, Drug Controller General of India (DCGI).

The panel will review the Drugs and Cosmetics Act, 1940, and come up with a new law to regulate drugs in the country. The panel is expected to submit a draft by November 30 that will help formulate the new Drugs, Cosmetics and Medical Devices Bill which could be taken up in the Indian Parliament to be enacted.

India's Drugs and Cosmetics Act regulates the import, manufacture, distribution and sale of drugs and cosmetics. India’s apex regulatory body, the Central Drugs Standard Control Organization (CDSCO) has an overarching role.

Attempts have been made by policy makers in India to address the serious problems facing the country's drug regulation system. Several issues that ail the system have been pointed out by industry groups and generic companies, including poor regulatory infrastructure and poor performance, lack of access to safe and effective medicines and poorly regulated clinical trials.

In 2012, India's Standing Committee on Health and Family Welfare had criticized the CDSCO on its functioning and was also critical of marketing approvals being granted for drugs without clinical trials, especially trials in the Indian population.

The drugs Act has been termed obsolete by several generic players as it was formed in 1940. Though it has undergone multiple amendments, the current Drugs and Cosmetics Act is deficient, said an industry representative.

Growing centralization of drug regulation also poses problems

The growing centralization of drug regulation also poses problems. It began as a clear distinction between the central government (responsible for importing drugs) and the states (responsible for manufacturing, distribution, and sale), but over time the lines have blurred and central control expanded.

Criticism was also levied that India has badly drafted and weak rules on clinical trials. Officials said the current Drug Act allows the central regulator to exercise discretions that are not subject to transparency and accountability mechanisms.

The new committee will undertake pre-legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft document for a de-novo Drugs, Cosmetics and Medical Devices bill.