Why DCGI served a show-cause notice on e-pharmacies

Although there isn’t any specific legislation in India regulating the sale of medicines online, the DCGI notice quotes the Delhi High Court’s order in the matter of Dr. Zaheer Ahmed Vs The Union of India.

The Delhi High Court (HC) had ordered state drug regulators to prohibit the sale of medicines online without a licence, and had asked them to ensure compliance until further orders.

India’s apex drug regulator has alleged that even after the top regulatory body had told e-pharmacies to comply with the HC order, e-pharmacies were found to be selling medicines online without a licence.

What are the laws being violated?

V G Somani, the Drug Controller General of India, has alleged that online pharmacies were violating Section 18 (C) of the Drugs and Cosmetics Act, and rules 62, 64, and 65 of the Drugs and Cosmetics Rules.

Rule 64 prescribes the conditions to be satisfied before a licence to sell drugs may be granted to an applicant.

Rule 65 prescribes the conditions of the licence to be complied with by the licensee.

The regulator has said that under Rule 62, if the drug is sought to be sold or stocked for sale at more than one place, a separate application needs to be made for each such place.

Also read: Small retailers, wholesalers are up in arms against pricing, discounts of online pharmacies

The regulator said that a licence from the concerned state licencing authority is required to sell, stock, exhibit, distribute, or offer to sell any drug, and that the licencee also needs to ensure compliance with the licence conditions.

“The sale, or stock (sic) or exhibit or offer for sale or distribution of drugs through online, internet, or other electronic platforms without a licence has potential impact on the quality of drugs and pose (a) risk to public health due to the potential misuse of drugs through self-medication, (and) indiscriminate use of drugs,” Somani’s notice to the e-pharmacies said.

Distributing Schedule H drugs

According to a top health ministry official, numerous petitions are being heard in several high courts challenging the online sale of drugs specified in Schedule H, HI, and X, which are only allowed to be sold under the valid prescription of a registered medical practitioner by a registered pharmacist.

“The government is considering bringing in legislation to regulate the online sale of medicines. There are reports that schedule H drugs are being sold online without a prescription,” the official told Moneycontrol.

The All India Organisation of Chemists and Druggists (AIOCD), which has been a key opponent of online medicine sales, has alleged that no records are maintained by e-pharmacies while selling Schedule H drugs.

“The retailers have to maintain a register for all drugs sold under Schedule H capturing details like the name of the drug, the prescribing doctor, date, name of patient, etc. But nobody checks whether online sellers comply with this or not,” said Rajiv Singhal, General Secretary, AIOCD.

Montu Patel, President, Pharmacy Council of India, said that online sales of medicines was wrong and urged the government to come out with legislation for regulating this.

Moneycontrol reached out to several e-pharmacies for their response to the DCGI notice, only Flipkart Health+ has responded so far on the story.

An official on behalf of Flipkart Health+ said that its digital healthcare marketplace platform enables easy and convenient access to genuine and affordable medicines and healthcare products, from independent sellers, for millions of customers across the country.

"We have received the notice from Central Drugs Standard Control Organisation (CDSCO) and are responding to it appropriately. As an organisation we remain committed to comply with the laws of the land and towards continuous improvements of our processes/checks and controls on our marketplace platform to build trust and enhance customer experience," the official said.

The calls and messages to TATA1mg's founder Prashant Tondon went unanswered. The story will be updated if the online pharmacies respond to the queries.