Drug firms failing quality check may lose licence

Drugmakers failing random quality checks could potentially be deemed guilty until proven innocent under a fresh crackdown by the Centre on substandard, spurious and adulterated medicines.

- Priyanka Sharma

The government plans to suspend the product permission licence issued to a drug-maker for a particular medicine if even a single batch of that medicine is found to be substandard by any government testing laboratory, said two officials, requesting anonymity.

In effect, a drugmaker will not be allowed to keep manufacturing a particular medicine after just withdrawing a failed batch, as is the current practice.

India's Drugs Rules, 1945 has no provision on actions to be taken if a batch of medicines fails a quality test, apart from those specific medicines being declared as not-of-standard-quality (NSQ).

A drugmaker's licence for that particular drug is suspended only if a probe proves wrongdoing on the part of the firm—an often lengthy process.

The planned rule changes would also have a bearing on the global pharmaceutical industry. India, which manufactures 60,000 generic brands across 60 therapeutic categories, is the largest global supplier of generic drugs, accounting for about 20% of the global supply.

Given the lacuna, states resort to ad-hoc actions, and in the process fail to check subpar manufacturing practices that have dented India's image as the "world's pharmacy".

States and Union territories are empowered to take action against a drugmaker if a batch of medicines fails a quality check. This includes asking a manufacturer to withdraw a product or suspend the product permission licence if a drugmaker is at fault.