Tear up the rules and start again, Lancet panel says to India on drug safety

SINGAPORE--One of the world's most prestigious medical journals called for India to abandon its current proposal to change the way it regulates drugs and come up with a new plan.

A four-person panel, including an Indian physician, wrote in the journal Lancet that the 2013 Indian Drugs and Cosmetics (Amendment) Bill as it stands "will not deliver rational, safe and effective regulation of drugs."

The analysis of the panel of health and legal experts proposed at least 9 changes in the proposed new law to help fix what they called "serious problems" in the current drug-regulating system. Earlier, India's Parliament rejected two major parts of the proposal that would have replaced the current regulatory body with a more powerful one with exported drugs under its jurisdiction.

Ironically, the same Parliament panel had sparked the bill with its own criticism of the Central Drugs Standard Control Organisation. The proposed bill would call its replacement the Central Drugs Authority.

The four analysts said their team analyzed India's drug approvals over the past 42 years, plus 7 decades worth of legal changes in the law, to arrive at its conclusion. They singled out fixed-dose combinations (FDCs) for criticism, saying India is awash in them. The Times of India newspaper said there were an estimated 5,000 available in India, mainly including the controversial metformin.

The four-person panel said a new law needs to state the new CDA's purpose in the statute, that its job would be "approving safe, effective and high-quality drugs that are medically needed and therapeutically justified." It also should be required to ensure that new drugs, including FDCs, are of high quality and medically needed, and if not, they would not be approved, they said.

Among other proposals, the analysts said the CDA should be required to prioritize approval application reviews according to the nation's need of the moment and the therapeutic justification made for the drug. Also, they said, make it clear to drugmakers when clinical trials, particularly for combinations, are necessary, and align the regulations for the FDCs with World Health Organization guidelines.

They also would add a requirement for postmarketing review of combos and periodic review of all drugs on the market to determine if they are still relevant to the nation's medical needs. Regulations also should be restructured to allow decisions to be overridden in the public's interest and according to disease activity.

The analysts noted that India's drug-regulation system has been widely criticized in various reports as having a weak infrastructure and "poor performance, lack of access to safe and effective medicines, badly regulated clinical trials and the proliferation of fixed-dose combinations."

In summary, the Lancet report said, "Such an act should have clearly drafted rules requiring rigorous and transparent evidence that supports the effectiveness and safety of new drugs in the context of public need."

- here's the Lancet report
- and the Times of India piece