Pharma biggies among 200 under lens for poor drugs

The Drug Controller General of India has launched inspections against 200 drug makers, including leading firms like Cipla and Pfizer, for allegedly selling poor quality medicines and non-compliance to manufacturing norms.

"We have already inspected 36 drug manufacturing plants over last three months. In the second phase, starting from Monday, we will conduct inspections in 20 more facilities, “an official in the health ministry told TOI.

According to a source, notices have been issued recently to Cipla and Pfizer informing them of the upcoming inspection as well as violations found in their products. Cipla maintained it has not received any intimation so far. Pfizer did not comment.

This is for the first time inspections on this scale have been undertaken by the domestic regulator. The move also assumes significance as it comes in the wake of the recent regulatory ban on 344 fixed dose combination drugs.

The 200 companies, where "risk-based inspections" are being carried out, have been listed based on three criterion. "We have analysed regulatory data for last five years and listed companies where violations were reported regularly. Besides, complaints from international agencies and importers of medicines from Indian plants have been considered," the official said.

The regulator has also drawn drug samples from the market through surveys and gathered inputs from state authorities to identify the firms.

The 36 plants already inspected are based in Tamil Nadu, Uttarakhand, Maharashtra and Himachal Pradesh. The health ministry had also organised special training programmes for drug inspectors to ensure objectivity and transparency.

Indian pharmaceutical manufacturing plants have been on the radar of international agencies. Ranbaxy Laboratories, now part of Sun Pharma, had to stop supplies after the US FDA pointed out major violations. Pharmaceutical exports are expected to cross $20 billion by 2020 from $14 billion in 2016.

Source: http://timesofindia.indiatimes.com/india/Pharma-biggies-among-200-under-lens-for-poor-drugs/articleshow/52842920.cms