India's drug control organisation has been rapped for thousands of untested and substandard combination drugs available in the market. And short duration trials conducted by multinational companies did not meet international standards of safety and efficacy.
Medical journal Lancet has blamed India's Drug Act for the proliferation of the harmful combination drugs not tested or validated in clinical trials available in the market.
Fixed dose combinations of metformin used to treat diabetes highlights the practice of evading approval and price controls, said the study highlighting the need for scientific data.
"India's Drug Act makes it possible for FDCs [fixed dose combinations] to evade CDSCO [Central Drugs Standard Control Organisation] approval and is in urgent need of an overhaul," Lancet said in its analysis, shared with the Times of India.
Many substandard combination drugs including the frontline diabetes drugs are available in the country.
Banned by national and international guidelines, the metformin drug combinations are marketed by over 500 brands in the country. These include Amaryl MP, Gemer P1, Glimy M, Glyciphage PG1 and Pioglar GF.
Globally, metformin combinations are not used.
"Our research shows that the short-duration trials sponsored by multinational companies failed to consider the balance of any possible advantage of FDCs over potential disadvantages, and did not provide robust evidence of the efficacy and safety of these combinations.
"Furthermore, when these trials were scrutinized against WHO guidelines for approval of FDCs, none met the recommended criteria for efficacy and safety. We concluded that CDSCO must make public the evidence it used when granting approval of metformin FDCs and the basis for efficacy and safety," Lancet says.
The article points to a lack of rationale for drug approvals behind the 41 metformin combination drugs.
The drug regulator does not publish grounds for new drug approvals, while the country's clinical trials registry, which has been mandatory only since 2009, has no data of these trials conducted in India, said Lancet.
An expert committee had also noted that about 85,000 drug formulations available have no scientific basis for their approval.
A parliamentary report found that new drug approvals were being granted without the necessary clinical trials, especially oral fixed dose combinations.