India: 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 (DCGI) 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 recent raids 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 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, informed 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, Dr. Reddy said show-cause notices would also be sent to the companies marketing these medicines which included Wockhardt, Medley Pharmaceuticals, Galpha Laboratories, Nectar Biopharma, Biological 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 was quoted as saying in news reports.