New Delhi: A total of 7,700 samples of medicines were declared not of standard quality and 670 declared spurious or adulterated out of a total 84,874 samples picked for testing during the last three years.
The government data disclosed that a total of 2,652 samples of medicines were declared not of standard quality and 263 were declared spurious or adulterated out of a total of 84,874 samples picked for testing during the year 2020-21.
Enforcement actions were carried out in terms of samples tested, number of drug samples declared sub-standard and spurious/ adulterated during the last three years. While 164 persons were arrested as the authority concerned initiated prosecutions in the year 2020-21, over 500 such arrests were made in the last three years.
In a reply to a question in the Lok Sabha on Friday, the Ministry of Health and Family Welfare said that the manufacture, sale and distribution of drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945. 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 respective state governments. The SLAs are legally empowered to take action in case of violation of the condition of licence.
The government has taken measures, including strengthening of legal provisions, workshops and training programmes for manufacturers and regulatory officials and measures such as risk-based inspection.
In cases of fake and spurious drugs, various enforcement actions like drug seizure, arrests of accused persons/registration of FIR etc., have been carried out by the states/UTs/Drugs Controllers. The Central Drugs Standard Control Organization (CDSCO) and the Union Ministry of Health and Family Welfare have taken various regulatory measures to ensure the quality of medicines distributed in the country.
The Drugs and Cosmetics Act, 1940 was amended under the Drugs & Cosmetics (Amendment) Act, 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable. Besides, the states/UTs were requested to set up special courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. So far, 33 states have already set up designated special courts.
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