Show cause notice sent to 31 firms following concerns over online drugs sale: Govt to Lok Sabha

Over 30 firms have been sent a show cause notice by India’s national regulatory body for cosmetics, pharmaceuticals, and medical devices, Central Drugs Standard Control Organisation (CDSCO) following concerns over the sale of drugs online or through other electronic platforms in contravention to the provisions of the Drugs and Cosmetics Act, 1940, the government informed the Lok Sabha on Friday, March 17.

Cases involving drug quality were taken up with the relevant State Licensing Authority (SLA) for necessary action under the provisions of the Drugs and Cosmetics Act, said Minister of State for Health Bharati Pravin Pawar in a written response.

The SLAs are empowered to take action on violation of conditions such as licenses, including prosecution in an appropriate court of law.

Bharati also told the Lower House of Parliament that as informed by CDSCO, various representations are received raising concerns regarding the sale of drugs through online or other electronic platforms in contravention to the provisions of the Drugs and Cosmetics Act, 1940.

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Based on findings in these representations, CDSCO issued show cause notices on February 8 and 9 to 31 firms engaged in the online sale of the drugs, Pawar said.

The CDSCO and Ministry of Health have taken regulatory measures to ensure the quality of medicines in the country as part of which the Drugs and Cosmetics Act, 1940, was amended under the Drugs and Cosmetics (Amendment) Act, 2008, to provide stringent penalties for manufacture of spurious and adulterated drugs, the minister said in her written reply.

Certain offenses have also been made cognizable and non-bailable. States and Union Territories have set up special courts for the speedy disposal of trials of offenses under the Drugs and Cosmetics Act.

The number of sanctioned posts in CDSCO has significantly increased in the last 10 years and to ensure the efficacy of drugs, the Drugs and Cosmetics Rules, 1945, have been amended providing that the applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of the oral dosage form of some drugs.

With the amendment of the rules, it has also been made mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of central and state governments, Pawar said.

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