1 drug sample spurious and nearly 48 substandard in June inspection

Around 48 of the 1,273 drug samples tested for quality in June were found to be of non-standard quality (NSQ). Samples from two public-sector pharmaceutical firms also featured in the list, as did some of the reputed pharma firms.

According to a document seen by Business Standard, 1,273 drug samples were tested by government laboratories across the country in June. Of them, 1,225 samples were declared of standard quality. One sample was found to be spurious and 48 were of non-standard quality.

The Central Drugs Standard Control Organisation (CDSCO) runs the exercise regularly. State drug inspectors pick up random samples that are in circulation, which are tested at government-accredited laboratories.

The inspection gains significance in the wake of the recent controversies surrounding sub-standard and contaminated drugs manufactured in India and exported to African, Latin American, and Asian countries.

In the 48 samples tested NSQ, several are from Haryana, Uttarakhand, and Punjab. Common medicines like aspirin, anti-cholesterol (rosuvastatin), vitamins, steroids, anti-diabetic, anti-inflammatory drugs and antibiotics feature in the list.

Eye-drops made by Indiana Ophthalmics in Gujarat that have been under the scanner also feature in the list.

The list for paracetamol and antibiotics also includes samples from two pharmaceutical PSUs –- one each in Pune and Bengaluru.

A large unlisted pharma company from Ahmedabad also features in the list for NSQ samples of common antacid ranitidine. These were drawn in Sikkim and were tested in Guwahati. Pantoprazole (acidity drug) samples from a Mumbai-based listed firm with a turnover close to ~10,000 crore drawn by drug inspectors in Goalpara and Bhagalpur also tested NSQ in a government laboratory in Guwahati.

Earlier in July the Centre made Schedule M of the Drugs and Cosmetics Act 1940 would be made compulsory for small and medium manufacturers in a phased manner.

Union Health Minister Mansukh Mandaviya has asked micro, small, and medium enterprises (MSMEs) in pharma manufacturing to move towards good manufacturing practices (GMP) through self-regulation. “This will help in quality assurance and reduce compliance burden,” Mandaviya had said.

The Schedule M of the Drugs and Cosmetics Act 1940 deals with good manufacturing practices for pharma manufacturing units in India.

The minister’s statement comes amid reports surrounding contaminated and substandard cough products sent from India to countries like Gambia, Uzbekistan, and Sri Lanka. The Centre has made testing of cough syrups mandatory at government labs before they are exported.