Pfizer, Dr Reddy's among 66 firms that fail govt test for NSQ drugs

Firms enter list if 5 drugs made by them fail test; Pfizer has 25 samples, Alembic, DRL have 9 each

The Central Drugs Standard Control Organisation (CDSCO) has declared that 66 pharmaceutical firms have failed the test for Not of Standard Quality (NSQ) drugs. Major companies, including Zydus Healthcare, Dr Reddy’s Laboratories, Cipla, Alembic and Pfizer, are part of the list released by the government on Friday.

At least five drug samples picked up by the government failed the test, following which the companies were put on the list. The findings showed Pfizer failed the test for 25 samples, while Alembic and Dr Reddy’s Laboratories had nine NSQ quality drugs. Seven drug samples of Cipla, and six of Zydus Healthcare, too, failed the test.

                                                       

Apart from the large private firms, government enterprises such as Karnataka Antibiotics and Pharmaceuticals and Kerala State Drugs and Pharmaceuticals also feature in the list. Around 15 samples drawn from Karnataka Antibiotics and Pharmaceuticals, and 14 from Kerala State Drugs and Pharmaceuticals were declared substandard by the Ministry of Health and the central drug regulator. In certain other cases, 61 samples failed the quality test. 

Pfizer stated in an email, “We are unable to confirm the authenticity of the products picked or confirm evidence of the alleged deficiencies as the due process of providing a sealed market sample was not followed. Upon testing of control samples at independent FDA approved laboratories, our products were found to be fully compliant with all required specifications. This was duly communicated to the regulatory authorities and no further action was recommended.” It added that Pfizer placed the utmost importance on product quality and patient safety. “All Pfizer products released in the market meet every national and international testing specification.”   The other companies did not respond to Business Standard’s queries.

In an earlier NSQ determination test administered by the health ministry in February, 3.16 per cent of the drug samples taken from retail outlets were not of standard quality. According to this survey, the estimated percentage of NSQ drugs from government sources was 10.02 per cent and for spurious drugs it was 0.059 per cent. Globally, the acceptable rate is around 2 per cent.

The Drug Controller General of India (DCGI) had earlier stated that India would take at least two years to reach a stage where only 2 per cent of the drugs were of not of standard quality. Meanwhile, the government has started risk-based assessment to keep a constant check on companies and their manufacturing units in an attempt to improve manufacturing practices. As of now, risk-based assessment is undertaken in India alone. It is learnt that the country’s drug regulator plans to conduct such an assessment abroad, on the line of the US FDA and EU regulators. India exports drugs to around 200 countries and the government is working with these countries to ensure that manufacturing practices are up to global standards.

The statistical design of the drug survey included 224 drug molecules belonging to 15 different therapeutic categories of the National List of Essential Medicines (NLEM), 2011. As part of this survey, 47,954 drug samples relating to 23 dosage forms were drawn from 654 districts of 36 states and Union Territories from the supply chains, including retail and government outlets.