Generic Drugs - New Rules mooted on drugs disburse by doctors

Generic Drugs - New Rules mooted on drugs disburse by doctors


Context :- The Central Government is considering amendments to the Drugs and Cosmetic Rules, 1945 to ensure that registered medical practitioners dispense only generic medicines.

What are generic drugs?
  • A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by patents.
  • Generic drugs are allowed for sale after the patents on the original drugs expire.
  • Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance.
  • A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Prescribing generic drugs
  • The matter was recently brought before the Drugs Consultative Committee (DCC) of the Central Drugs Standard Control Organisation (CDSCO).
  • A proposal attempts that registered medical practitioners can supply different categories of medicines including vaccines to their patients under the exemption provided, with certain conditions, under Schedule K of the Drugs and Cosmetics Rules, 1945.
  • It is now proposed that registered medical practitioners shall supply generic medicines only and physicians samples shall be supplied free of cost.
Issues with generic drugs
  • The main concern is to offer the best medicines which are most effective so medical professionals should not be forced to prescribe in a particular manner.
  • The government has to ensure easy availability, unclogged supply chain, and strict quality control of generic medicines.
  • It also has to ensure availability and effectiveness also of generic medicines.
Way forward
  • The government should keep strict price control on medicines and ensure that the highest quality medicines are given to the patients.
  • All laws, checks and balances should be directed at giving the best possible treatment at the best cost.

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