Online pharmacies will now be monitored by FDA’s rule book

A draft policy has been submitted, which mandates that the sale of drugs online will be brought under the ambit of the Drugs and Cosmetics Act, 1940

The idea of regulating operations of online pharmaceutical companies has been tossed around at various internal meetings of the state Food and Drug Administration (FDA) since the last three years. It is only now that FDA has formulated a draft policy, which has been submitted to the ministry of health and family welfare, to bring the sale of online medicines under the ambit of the Drugs and Cosmetics Act, 1940. Officials hope that this will help stem the mushrooming of fly-bynight operators.

Some of the salient features of the policy are: Monitoring the sale of medicines online, checking the quality of the drugs sold and setting up a grievance redresal mechanism to solve customers’ problems. The draft, which has been penned by former FDA commissioner Harshdeep Kamble and his team, mandates that e-pharmacies must be registered with the government, where the privacy of the patients is sacrosanct. The companies may only disclose the identities to the Central government, if the need arises. All data generated must be kept localised and not shared by any means outside the country.

If a customer is suspicious about the quality of medicines received from an e-tailer, he/ she can file a written complaint to the respective state drug controller. In doing so the customer can seek relief under the Consumer Protection Act, 1985.

The e-pharmacies have to periodically update their website on the availability of the type of drugs on sale, the supply chains and vendors list. The website should also be updated with details of physicians or registered medical practitioners if any, in compliance with the Drug and Cosmetics Act.

As soon as an e-pharmacy receives a prescription from a customer, the name of the patient and the registered doctor should be verified before dispensing the drugs; also, this should be in compliance with the registered medical practitioner. The e-pharmacy must also have a qualified pharmacist on board, with details of his place of work.

The registration of the e-pharmacy will be valid for three years and renewed thereafter. It must be exempt from advertising any drug in the media. The premises where it operates from will be inspected by a team of officers and an expert, authorised by the central licensing authority, once every two years.

The licences can be cancelled or suspended according to the provision of the Drugs and Cosmetics Act , where the company can, within 45 days of the suspension or cancellation, appeal to the Union ministry of health and family welfare for a hearing.

Elucidating the need for such a rule, Pallavi Darade, state commissioner of FDA, said, “There are several online pharmaceutical companies that are operating without licences. The quality of the medicines are often compromised and very often they are issued without prescriptions. There is no data or record to fall back on.”

Adding to her argument, R P Chaudhari, assistant commissioner, FDA (drug), Pune region, said, “We have found many companies operating from neighbouring states selling scheduled drugs without proper prescription. This needs to be strictly monitored.”

Chaudhari further added that the approval of the draft will help the department weed out charlatans, given that there are “cases against more than seven online players filed by us are various incidents a couple of years ago, where they have yet to respond to our notices ”.