‘States must recall drugs, combination medicines sold without DCGI nod’

In an effort to close the tap on new drugs and combination medicines entering the market without regulatory approval, the Drug Controller General of India is writing to State regulators to review and recall such medicines already in the market.

The DCGI has also urged the Health Ministry to alert State health authorities to not give manufacturing approvals to new drugs and combination medicines that have not been approved by the Central regulator or the DCGI.

The development follows raids last week by the Central Drugs Standards Control Organisation (CDSCO) on manufacturing plants in Haridwar and Roorkee (Uttarakhand) that were making drugs not approved by the Central authority, which is against the law. Over 70 of the 118 products there were found to be without the DCGI’s approval, though they had been licensed by the State licensing authority.

Dr Eswara Reddy, the recently appointed DCGI, told BusinessLine that it was unfortunate that some authorities, especially in smaller States, were giving manufacturing approvals to companies, despite knowing that a new drug or combination medicine needs to be cleared first by the DCGI.

While the office of the DCGI has sent show-cause notices to Mascot Healthcare and Ambic Aayurchem whose plants were raided, Reddy said show-cause notices would also be sent to the companies marketing these medicines which included Wockhardt, Medley Pharmaceuticals, Galpha Laboratories, Nectar Biopharma, Bilogical E and Dr Morepen among others.

The DCGI's office is writing to other State authorities to not just review and recall such medicines in their markets but to also communicate that with other State authorities, a CDSCO representative said.

Patient risk

In December 2017, the Supreme Court had cleared the air on fixed doze combination (FDC) medicines (that involve two or more medicines in one pill/product) by allowing the Centre to order FDC drugs off market-shelves , if they were found to be unsafe. This came after much litigation, following the Centre’s ban of 344 FDCs in 2016.

State authorities and large drug companies need to be aware that they should not be approving or marketing new drugs or FDCs respectively, that have not got DCGI approval. It is of great concern, Reddy said, citing the 59th Parliamentary Standing Committee report on Health and Family welfare that had flagged the issue and observed that drugs sold without safety and efficacy trials put patients at risk.

Drug resistance

The Indian FDC problem also came up in a study undertaken by researchers at the Queen Mary University of London and Newcastle University. The research found that multinational companies manufactured many unapproved formulations, despite pledging to tackle rising antimicrobial resistance, a note on the study, issued earlier this year, said. (Drug resistance results from erratic exposure to or consumption of a drug, say an antibiotic, that renders it ineffective in curing an illness.)

Of 118 different FDC formulations sold in India between 2007 and 2012, the team found that 64 percent (75) were not approved by the national drugs regulator, the CDSCO, even though the sale of unapproved new medicines is illegal in India. Only five of the formulations were approved in the UK or US, the note added. The 118 FDC formulations gave rise to over 3300 brand-named products made by almost 500 pharmaceutical manufacturers, including multinational companies.

In fact, the study’s lead author Dr Patricia McGettigan from Queen Mary pointed out, “Selling unapproved, unscrutinised antibiotics undermines measures in India to control antimicrobial resistance. Multinational companies should explain the sale of products in India that did not have the approval of their own national regulators and, in many cases, did not even have the approval of the Indian regulator.”

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