Definition of generic drugs discussed in Parliament

He said that the generic medicines are generally those which contain some amount of same active ingredients in same dosage form, and are intended to be administered by the same route of administration as that of branded medicine.

New Delhi: The Minister of State in Ministry of Health and Family Welfare Ashwini Kumar Choubey said that there is no definition of 'generic drugs' in the Drugs and Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945, on Tuesday in Lok Sabha.

"The quality of drugs imported, manufactured and sold in the country is regulated under the provisions of Drugs and Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. And there is no definition of generic drugs under these acts", he said.

He said that the generic medicines are generally those which contain some amount of same active ingredients in same dosage form, and are intended to be administered by the same route of administration as that of branded medicine.

"The medicines, whether branded, generic or branded-generic, imported or manufactured for sale/distribution in the country, are required to comply with the same standards as specified in the Second Schedule to the Drugs and Cosmetics Act, 1940", the minister said.

He also stated that these medicines are available easily in the country, especially in Delhi. Further, "Public Health & Hospitals" being a State subject, the primary responsibility of ensuring the sufficient supply of free medicines is that of respective State Governments.

In an answer on the National Health Mission, Chowbey said, "Under the National Health Mission, the Central Government supplements the efforts of State Governments to strengthen their healthcare system including for the provision of free essential medicines in public health facilities, based on proposals of the State Governments."

"Under the NHM, financial and technical support is provided to the States and Union Territories not only for provision of essential drugs (mostly all generic), free of cost, in public health facilities but also for strengthening or setting up robust systems of procurement, quality assurance mechanism, warehousing, prescription audit, grievance redressal, dissemination of Standard Treatment Guidelines, and IT backed supply chain management systems like Drugs and Vaccines Distribution Management Systems (DVDMS)" he further added.

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