New rules mooted on drugs dispensed by doctors

  1. The Central Drugs Standard Control Organisation(CDSCO) has suggested amendments to the Drugs and Cosmetic Rules,1945 to ensure that registered medical practitioners dispense only generic medicines.
  2. A generic medicine is a copy of drug medication created to be the same as an already marketed brand-name drug.It is equal in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
  3. As of now there are no specified types of medicines which can be supplied by doctors to their patients.
  4. However,Indian Medical Association(IMA) has welcomed the move to keep drugs affordable but said that the government has to ensure availability and effectiveness of generic medicines.
  5. Further,IMA has said that the main concern is to offer the best medicines which are most effective so they said that doctors should not be forced to prescribe in a particular manner.
  6. The Central Drugs Standard Control Organization(CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device It functions under the Drugs and Cosmetics Act.CDSCO comes under Directorate General of Health Services,Ministry of Health & Family Welfare.
  7. CDSCO is responsible for (a)approval of New Drugs (b)Conduct of Clinical Trials, (c)laying down the standards for Drugs (d)control over the quality of imported Drugs in the country and (e)coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.