New Delhi: A latest study has revealed that India's Drug Act has aided proliferation of harmful combination drugs without any clinical trials and with little medical rationale.
Many of such drugs are easily available on retail stores, world's best known general medical journals, The Lancet, stated while suggesting that the regulator should withdraw all licences until the manufacturers provide scientific rationale for their safety.
The Lancet findings, which were shared with Times of India, said that the Drug Act has helped harmful fixed dose combinations (FDCs) of metformin, used for managing diabetes, to evade approval of Central Drugs Standard Control Organisation (CDSCO).
It mentioned that that India's Drug Act makes it possible for FDCs to evade CDSCO approval and called for an urgent need of an overhaul.
Metformin FDCs are not recommended by international or national treatment guidelines for diabetes control. Over 500 marketed brands are available in the country.
Globally, there is little use of metformin combinations, it said.
41 metformin FDCs have been approved for diabetes in India but the rationale is not clear as the drug regulator does not publish grounds for new drug approvals. Country's clinical trials registry, mandatory since 2009, has no data of such trials conducted in India.
What is more irony, when these trials were scrutinized against WHO guidelines for approval of FDCs, none met the recommended criteria for efficacy and safety, Lancet said in its report.
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 added.
Sales volumes of metformin FDCs account for 56 per cent of all oral diabetic drug sales. Some of the top-selling metformin combination medicines include Amaryl MP, Gemer P1, Glimy M, Glyciphage PG1 and Pioglar GF.
Earlier, an expert committee chaired by Ranjit Roy Chaudhury had suggested that about 85,000 drug formulations available should not be marketed at all since the scientific basis for their approval is in need of urgent review.
