Worrying disclosure after cough syrup: 462 medicine samples declared spurious during 2019-21

New Delhi: Highly worrying official data tell that 462 samples of medicines were declared adulterated or spurious during 2019-21, a disclosure that comes close on the heels of WHO warning about Indian cough syrups linked with the death of over 60 children in Gambia.

The authorities have swung into action and ordered a detailed investigation into the cough syrups produced and exported to Gambia by an Indian company.

A total of 81,329 drug samples were tested in 2019-20 out of which 2497 samples were declared as not being of standard quality and 199 were declared of spurious nature. Similarly, in 2020-21, out of the total 84874 samples lifted for testing, 2652 samples were declared not of standard quality while 263 were found to be spurious. A total of 220 and 164 people were arrested in 2019-20 and 2020-21 respectively.

Officials said that the government has taken a series of measures including strengthening of legal provisions, workshops and training programmes for manufacturers and regulatory officials and steps such as risk based inspection.

As per a recent Parliament reply, the government has taken various regulatory measures since 2019 to ensure the quality of medicines in the country. The Drugs Rules, 1945 were amended providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label. The stored data or information shall include the minimum particulars including unique product identification code, Batch No, manufacturing date, expiry date.

The Drugs Rules, 1945 were amended providing that any person who sells or distributes any drug shall be responsible for the quality of that drug as well as other regulatory compliances along with the manufacturer under these rules.

The rules were amended providing that “in case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the Licensing Authority to the effect that to the best of his knowledge based on search in trademarks registry, central database for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation, literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market,” said the reply by the Ministry of Health.

The regulatory control over the manufacture, sale and distribution of drugs in the country is exercised through a system of licensing and inspection by the State Licensing Authorities (SLAs) appointed by the state governments.

Earlier this week, the World Health Organization (WHO) issued a warning about drugs manufactured by a Haryana-based pharmaceutical company following which the Union government initiated a probe. The cough syrups have been linked with the death of over 60 children in Gambia. An initial enquiry has found that these drugs were not sold in India and were meant for export. The government has also said that the samples of the four syrups have been sent for testing and action will be initiated after the test results. IANS