Mumbai: The pharmaceuticals regulators of at least five states have asked around 800 large and medium drug makers to immediately withdraw the so-called ‘combination drugs’, which do not have central regulatory approval, from the domestic drugs market.
On 20 August, Mint had reported that such drugs could lose their licences.
The drug controllers in Maharashtra, Karnataka and Goa have sent notices to drug companies including top names such as Cipla Ltd, Nicholas Piramal India Ltd, Sun Pharmaceutical Industries Ltd, Alkem Laboratories Ltd, Lupin Ltd and Emcure Pharmaceuticals Ltd, asking them to pull back their combination drug brands from the market, and stop making these drugs with immediate effect.
Drug makers such as Cipla and Alkem have 37 drug combinations in the market, followed by others such as Nicholas Piramal and Cadilla Healthcare Ltd. Ranbaxy Laboratories Ltd, Lupin and Wockhardt Ltd, too, have combination drugs in their portfolio, according to the Central Drugs Standard Control Organization or CDSCO, the central authority that approves new drugs for marketing in the country.
Sun Pharma confirmed that it has received a notice from the Maharashtra state drug controller on five combination drugs.
A spokesperson said that the company “was awaiting approvals (for these) as per the new directive”. Ranbaxy, Cipla, Lupin and Alken did not respond to email and telephone queries.
State drug regulators in Andhra Pradesh and Tamil Nadu have asked some manufacturers to surrender manufacturing licences for such drugs. In Gujarat, the state with the largest concentration of drug making units in the country, the Food and Drug Control Administration has not initiated action yet as it is awaiting more clarity on the legality of cancelling licences.
This action follows a directive from the central drugs regulator, the office of the Drugs Controller General of India or DCGI, that the sale of such drugs—the industry makes some Rs4,000 crore selling nearly 3,000 combination brands, most of which are not approved by the Centre—is not in consumer interest because their efficacy and safety have not been tested. CDSCO is headed by DCGI M. Venkateswarlu.
Combination drugs are made by blending one key drug with one or more other drugs into a single pill or capsule for treating multiple conditions. The drugs are already approved in India individually but their combinations have not been tested and approved by the DCGI, as is the requirement for marketing all new drugs in the country. Manufacturing licences are separately granted by the states. Regulators in most countries insist on testing and approving such combination drugs as they would do with any other medicine. In fact, the World Health Organization does not recommend combination drug-based therapy unless it is found very essential for treatment in tuberculosis, malaria and HIV, among a few other diseases.
“Though these drugs are individually approved here, a combined formulation has to be treated as a new drug and the safety and efficacy tests have to be conducted again to clear them for marketing,” DCGI Venkateswarlu told Mint in an August interview. The Centre has prepared a list of 282 such drug combinations, also known in the industry as fixed-dose combinations.
An industry representative said the government move was unilateral. “The companies should be given time to present their data... Since the industry is ready to support the regulatory views, it (the government) shouldn’t have acted unilaterally...,” said Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance, a trade body that represents the country’s top 11 drug makers.
Some drug makers have applied for fresh drug marketing approvals for their combination brands. Nicholas Piramal has not received a notice from the state department “as it has already sought fresh (approvals) for combination products,” said Swati A. Piramal, the drug maker’s director of strategic alliances and communications. She added that 2,300 such applications are pending with the DCGI.
The DCGI said such marketing applications would be treated as per its standard process for new drugs. Such approvals typically take up to 18 months.
In Karnataka, Sripathi Rao, the state’s drug controller, said some manufacturers have started surrendering their licences. K. Selvaraju, drug controller of Tamil Nadu, said licences issued to three companies—Akson Laboratories Ltd, Kousik Pharmaceuticals Ltd and Tablets India Ltd—have been cancelled.