Central govt working to finalise rules on online sale of medicines

The existing regulations have no provision for selling medicine through the online route

The Central government is working to finalise the rules on online sale of medicines after dilly-dallying on the issue for nearly two years. The urgency to notify the rules comes after conflicting observations from the Delhi and Madras High Courts (HCs).

The Drug Controller General of India will soon notify these rules, a senior official from the agency said. Though the agency has so far not received any complaint against such pharmacies, these e-shops remain unlicensed in the absence of rules, the official said.

While the Delhi HC, which banned online sale of medicines on December 12, extended its ban till January 8, the Madras High Court overturned a single-judge order and allowed sale until formal rules were in place.

The absence of rules was a reason behind the Delhi HC’s decision. A two-judge Bench of Chief Justice Rajendra Menon and Justice V K Rao of the Delhi HC on December 18 observed that online pharmacies could start selling medicines once there were some rules in place. “Problem is that today there are no rules regulating it,” the Bench had observed.

In Chennai, six online pharma companies and a digital health platform formed by the major ones in the segment had sought to be impleaded in the original petition moved by the Tamil Nadu Chemists and Druggists Association (TNCDA). In their petition before the Madras HC, these companies said that there were nearly 20,000 people working in the sector catering to the demands of nearly 1.5 million customers.

TNCDA argues that existing regulations have no provision for selling medicine through the online route. The fact that draft rules for these were under consideration shows that the current online sales were not legal. Drugs, the association had said in its plea, could only be sold by a registered pharmacist against a prescription, and only from premises for which a licence had been issued by the regulatory authority.

The government initially thought of allowing only low risk and antimicrobial drugs to be sold by online pharmacies. In the latest draft rules, however, the government has plans of allowing all drugs to be sold online provided pharmacies demand a copy of a doctor’s prescription from the buyer and this prescription is then uploaded to a centralised server with the details of the patient.

Also, e-pharmacies cannot deal in drugs covered by the Narcotic Drugs and Psychotropic Substances Act, 1985, tranquillisers as well as drugs listed under Schedule X of the Drugs and Cosmetics Rules. At present, e-pharmacies require a retail license to sell drugs. These e-pharmacies tie up with local bricks-and-mortar pharmacies to distribute medicines to the consumer.

From a market size of $12.6 billion in 2009, the Indian pharma market is expected to grow to $55 billion by 2020, with the potential to reach $70 billion in an aggressive growth scenario. The e-pharmacy market has huge potential if it manages to capture a fraction of the off-line market.

 (With inputs from Gireesh Babu)