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Despite draft rules for a comprehensive regulation for online sales of medicines released almost seven years ago, and necessary provisions incorporated in the proposed new Drugs, Medical Devices and Cosmetics Bill, 2023 almost two years back, the Central government is yet to finalise a regulation that could control the fast growing e-pharmacy industry.
Responding to a question on regulation of online pharmacy platforms in the Rajya Sabha on July 22, Anupriya Patel, minister of state in the ministry of health and family welfare has mentioned that the draft rules were published in August, 2018, for inviting comments from public and stakeholders for amendment of the Drugs and Cosmetics Rules, 1945, for incorporating provisions relating to regulation of sale and distribution of drugs through e-pharmacy.
"The draft rules contain provisions for registration of e-pharmacy, periodic inspection of e-pharmacy, procedure for distribution or sale of drugs through e-pharmacy, prohibition of advertisement of drugs through e-pharmacy, complaint redressal mechanism, monitoring of e-pharmacy, data privacy etc.," she said.
However, the response to the question on the initiatives taken by the government to regulate the online pharmacy platforms especially to address the issues of data privacy, patient safety, and the risk of substandard or falsified medicine, is silent on any further development on enactment of the draft or any other regulation regarding the industry.
The draft, which adds a Part VIB under the Drugs and Cosmetics Rules, 1945, for sale of drugs by e-pharmacy was issued on August 28, 2018. Several developments both in terms of technology and in terms of penetration of e-commerce platforms have happened since then.
According to industry sources, the e-pharmacy industry is growing significantly with an annual growth rate of around 20% over the past five years. While the e-pharmacy operations in India is valued at around $1.4 billion, only around 5% of it is in the form of organised e-pharmacy.
While the new Drugs, Medical Devices and Cosmetics Bill, 2023, which is aimed at replacing the existing Act of 1940 and modernising and improving the regulation on drugs, medical devices, and cosmetics in the country, proposes to regulate the online pharmacies, this has also not been enacted so far.
The pharma traders in the country has been collectively opposing the online pharmacy sales and has been engaged in litigation in various Courts in the past, pointing out that the online sales of drugs is not allowed as per the existing rules and regulations. The central drug regulator has also time and again advised the state drug regulators to take action in case of any violation of the conditions of sale licenses.
As reported earlier, the South Chemists & Distributors Association's (SCDA), a trader's body based in Delhi, has been pursuing a petition seeking a ban on the online pharmacies in the Delhi High Court and the High Court has sought the ministry of health to submit an update regarding framing rules for e-pharmacies.
However, despite repeated opportunities from the Court to update regarding the framing of policy, the Centre in May, last year, stated that it has not been able to frame the rules. Following this, the Court proceeded to hear petitions to ban online sale of medicines on merit.
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