Legal framework still evolving for e-pharmacy business

In terms of the provisions of the said Rules, drugs specified in Schedules H, H1 and X cannot be sold except on, and in accordance with the prescription of a Registered Medical Practitioner from a licensed premises

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New Delhi: Currently, e-pharmacies which do not meet the requirements of Drugs and Cosmetics Rules, 1945 including those relating to sale from a licensed premises and maintaining necessary records, are not permitted, clarified the Minister of State (Health and Family Welfare), Mr Faggan Singh Kulaste recently.

In view of the concerns raised on the sale of drugs over internet, the Drugs Consultative Committee (DCC) in its 48th meeting held on 24th July, 2015, had constituted a sub-committee to examine the issue of sale of drugs on internet. The Sub-Committee, in its report, has inter alia recommended:-

  • Creation of a National Portal to act as the nodal platform for transacting and monitoring online sale of drugs.
  • Necessity of evolving a mechanism to register e-pharmacies.
  • Geographical restrictions for operation of e-pharmacies.
  • Mechanism for verification of authenticity through a link to the National Portal.
  • Existing licensees carrying out retail sale of drugs would also be able to register on the National Portal for carrying out online sale of drugs.
  • As certain categories of drugs viz. the Narcotic and Psychotropic drugs, tranquilizers, habit forming drugs and Schedule X drugs that are prone to being abused or misused to be excluded from sale through e-pharmacies.
  • Amendment of Drugs & Cosmetics Rules, 1945 for effective monitoring and proper enforcement of the Drugs & Cosmetics Act, 1940 for achieving its aims and objectives.

Meanwhile, the sale of medicine in the country continues to be regulated as per provisions of the Drugs and Cosmetics Rules, 1945 as amended from time to time. In terms of the provisions of the said Rules, drugs specified in Schedules H, H1 and X cannot be sold except on, and in accordance with the prescription of a Registered Medical Practitioner from a licensed premises. Therefore, any sale of such drugs other than from a licensed premise is not in conformity with these rules. Further, other requirements such as noting the name and address of seller and date on which medicines are dispensed can also not be met in many cases.

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