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A clutch of fixed-dose-combination (FDC) drugs, which the regulator thinks are irrational and of little use to patients, may be banned soon in what could hit a cross-section of the drug industry and dent the turnovers of leading firms like * Cipla, Sun Pharma, Cadila and Torrent, among others. These FDC drugs, which had found their way into the market without the approval from the drugs controller general of India (DCGI) and under licences issued by state drug regulators, include muscle relaxants, painkillers, anti-depressants and antispasmodics, according to official sources.
FDC formulations account for around 44% of the Rs 74,000-crore domestic pharmaceutical market and are frequently prescribed by doctors. A section of the FDC market is believed to be of drugs lacking any therapeutic efficacy (a recent study of a fairly representative size of this market said only 5% of the products are rational).
Concerned over the regulatory laxity at the state level which led to entry of these redundant medicines into the market, the drugs controller general has often used directions to the state authorities to refrain from giving approvals to these medicines, but compliance has been tardy in this front.
In regard to two dozen such drugs that are now facing a ban, the DCGI had set deadlines twice to all drug companies manufacturing/marketing these medicines to prove their safety and efficacy claims but hardly any company has complied with the directive. According to DCGI GN Singh, he has now asked these drug makers to submit the safety and efficacy documents regarding these combination medicines by September 30 or face an immediate suspension of the products.
“In case applications are not submitted by a manufacturer by September 30, 2013, it will be presumed that he is not willing to prove the safety and efficacy of such FDCs,” Singh told FE.
Under the Drugs & Cosmetics Act, only the DCGI is entitled to give marketing approval for any “new drug”, which include a first-time FDC of two or more drugs. Clinical trials are a must for these drugs for verifying their safety/efficacy profile, as also specified documentation. In practice, however, state licensing authorities routinely give approvals for new FDCs. A move is on to shift the licensing powers to the Centre under the Central Drug Authority Bill, which is pending in Parliament.
“There are doubts about the rationality of the FDC drugs (regarding which directions have been issued) and they may not be of any use to patients,” a health ministry official said.
The Central Drugs Standard Control Organisation (CDSCO) in March this year issued a comprehensive list of FDC drugs approved by DCGI which includes a total of 1,125 FDCs covering all therapeutic categories. This list is meant to be a ready reckoner for state regulators as well as doctors and patients.
A recent report in the International Journal of Basic & Clinical Pharmacology on "the irrational fixed-dose combinations in the Indian drug market" states that out of 278 FDCs (the report studied), only 5.4% were rational, and rest of the FDCs were irrational. Moreover, the most commonly prescribed FDCs were B complex, pantoprazole plus domperidone and amoxicillin plus clavulanic acid, said the report.
In 2007, the DCGI had come down heavily against sale of irrational combination medicines and states were asked to withdraw 294 FDCs that were licensed without the regulator's approval. However, the industry got a stay order on these FDCs from the Madras High Court. The matter is still sub judice, and a decision on these 294 FDCs will be taken after the outcome of the case, said the DCGI.
Recently, a parliamentary panel on health had also rapped the government on approving drugs without clinical trials and harmful fixed dose combinations. It had said "this inaction has led to unhindered marketing of these drugs with unknown and unspecified risks to unsuspecting people".