Drug regulatory body steps up heat on state units amid cough syrup lapses

India’s drug regulatory body Central Drugs Standard Control Organisation (CDSCO) has instructed all state drug controllers to ensure that raw materials used in medicines, including excipients and active ingredients, meet prescribed standards. The directive follows the tragic deaths of several children after consuming toxic cough syrups. The drug regulator, in a circular, noted that factory inspections and investigations of drugs declared as ‘not of standard quality’ (NSQ) have revealed that manufacturers are not carrying out testing of each batch of excipients.

It has now asked state drug controllers to ensure that the manufacturers have robust vendor qualification in place and use raw material, including excipients, from reliable and approved vendors only.

“This directorate has from time to time emphasised the critical importance of testing of raw materials including the excipients before their use in the manufacturing of pharmaceutical formulations,” said the circular issued by Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI). “All the state/ UT drug controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc.”

As per drugs rules, the licensee shall either in his own laboratory or in any laboratory approved by the licensing authority test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests, it noted. The regulator has asked the states to intimate it about action taken in this regard.

The story has been going on for some time. As reported by ET in December 2023, the drug regulator had found that the pharma industry was making use of industrial grade excipients unfit for human consumption for manufacturing medicines.

The regulator also received international complaints and it was observed during inspections that excipients like glycerin and propylene glycol had been imported from different countries as industrial grade. They were supplied by unlicensed traders, not licensed under the Drugs and Cosmetics Act and Rules, to pharma manufacturing units. There was evidence that low-cost industrial/technical-grade gelatin was being imported, mainly from China, by unscrupulous traders and sold to soft capsule manufacturers who blend it with high quality gelatin made in India, in the manufacturing of capsules.