Centre establishing legal framework to regulate online sale of medicines

The government is putting in place a legal framework to regulate online sale of medicines.

On Saturday, the government released the draft rules allowing one-point registration for e-pharmacies and fixing procedures for sale. The draft provides for patient data protection. The details of patients cannot be shared with anyone except government authorities.

The Drugs and Cosmetics Act, 1940, governs sale of medicines in India. Medicines can be sold from licensed premises only. The Act does not cover e-pharmacies at present and the government had decided to appoint a sub-committee, after receiving complaints of violations. The draft released on Saturday is based on the sub-committee's recommendations.

While the domestic pharmaceutical market size is around Rs 1.25 trillion, e-pharmacies constitute a minuscule portion of it. The collective sales are estimated to be around Rs 2 billion annually.

Under the proposed rules, individuals or companies will have to register with the central licensing authority to run an e-pharmacy;  state-wide registration is not required.

According to the rules, the e-pharmacy registration holder shall inform the central licensing authority regarding changes in constitution of the firm. A fresh registration will be required in the case of such changes and existing registration will be valid only for three months, it added. The e-pharmacy will have to mention on the website its constitution, details of directors and partners, name of logistics service provider, and return policy for dispensed drugs. 

Sources say brick-and-mortar chemists, too, have to inform about changes in their constitution to the licensing authority, but there is no requirement for them to display directors' names and shareholding details on their premises.

The e-pharmacy will have to adhere to provisions of the Information Technology Act.

The rules specify procedures for sale through an e-pharmacy. These state that on receipt of prescription, the registered pharmacist shall verify the details of the patient, registered medical practitioner and arrange the supply of drugs. The drugs will be dispensed through any licensed retailer or wholesaler of medicines. The details of the drugs dispensed, including the patient details, shall be maintained on the e-pharmacy portal. 

The premises from where the e-pharmacy business is conducted shall be inspected every two years by a team of officers authorised by the central licensing authority.

There will be restrictions on sale of drugs listed under narcotic and psychotropic category. An e-pharmacy will not be allowed to advertise any drug. "The rules are a great move to support the health care ecosystem. It is good for patients as e-pharmacies are required to maintain  customer support and a grievance redressal mechanism. However, the government should specify the period for which drug dispensation and patient details need to be kept by us," said. Dhaval Shah, co-founder of PharmEasy.in. “In the US, mail order pharmacies control 15 per cent of the market share. With the new regulations, e-pharmacies can see exponential growth in India as they will contribute to access and affordability,” said Pradeep Dadha, chief executive officer at Netmeds.