Drug sampling
NEW DELHI, July 25:
Over 2,500 drugs were found to be “not of standard quality”, while 379 were found to be spurious out of the 88,844 drug samples tested between April 2021 and March 2022, the Rajya Sabha was informed on Tuesday.
Minister of State for Health Bharati Pravin Pawar said 592 prosecutions were launched for manufacturing, sale and distribution of spurious or adulterated drugs during the same period, according to information received from drug controllers of various states and union territories.
In a written reply to a question, she said 84,874 samples were tested between April 2021 and March 2022 of which 2,652 were declared to be not of standard quality while 263 were found to be spurious.
She said 236 prosecutions were launched for manufacturing, sale and distribution of spurious or adulterated drugs during the same period.
Providing details of steps taken by the government for standardisation and quality improvement in the pharmaceuticals sector in the last five years, Pawar said the Drugs and Cosmetics Act, 1940 was amended under Drugs and Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs and certain offences have also been made cognisable and non-bailable.
Besides, states and UTs have set up special courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.
The number of sanctioned posts in CDSCO has been significantly increased in last 10 years, Pawar said.
To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicants shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.
The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by drugs inspectors of the Centre and state.
The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. To the State Licensing Authority before grant of manufacturing license by the authority, Pawar said.
The CDSCO coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act. The manufacturing, sale and distribution of drugs in the country are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945, Pawar said in her reply.
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 respective State Governments.
Pawar said manufacturers are required to comply with the conditions of license granted under the Act and Rules to manufacture any drugs for sale and distribution in the country. (PTI)
The cases concerning quality or safety of drugs are taken up with the State Licensing Authority in order to take necessary action under the provisions of Drugs and Cosmetics Act 1940 and its Rules.
The SLAs are legally empowered to take action of violation of any conditions of such licenses including prosecution in appropriate court of law, Pawar said. (PTI)
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