Regulating Online Pharmacy Business

A sub-committee had been constituted by the Drugs Consultative Committee (DCC) to examine issues relating to Online Pharmacy Business and sale of drugs. The Sub-Committee has submitted its report to the Drugs Consultative Committee.

The Sub-Committee has inter alia recommended

  • Creation of a National Portal to act as the nodal platform for transacting and monitoring Online Pharmacy Business and sale of drugs.
  • Necessity of evolving a mechanism to register e-pharmacies. 
  • Geographical restrictions for operation of e-pharmacies.
  • Existing licensees involved in retail sale of drugs could also register on the National Portal for carrying out online sale of drugs.
  • Requirement of registration with CDSCO under the Drugs and Cosmetics Rules, 1945. 
  • 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 be excluded from sale through e-pharmacies. 

Analysis

  • Online pharmacies laws in India are still in nascent stage and there are no dedicated online pharmacy laws in India. The Information Technology Act 2000 governs some of the legal issues pertaining to online dealings but it is silent on the aspect of online pharmacy. As a result, illegal online pharmacies have been increasing in India. If properly regulated, Online pharmacies in India could prove beneficial to various stakeholders.
  • The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have guidelines on the sale of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including for labelling. As most of the online pharmacies in India are not complying with Indian laws and the laws of other jurisdictions, they have been facing regulatory sanctions.

Conclusion

The Government has issued a notice seeking public comments on regulation of sale of drugs including introduction of an electronic platform for regulation of sale of drugs in the country.

Raj Malhotra IAS Study Group.