DCGI issues show cause notice to e-pharmacies for stocking & selling drugs in contravention to D&C Act
The Drug Controller General of India (DCGI) has issued a show cause notice to online pharmacies including Tata 1mg for allegedly stocking and selling drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules, once again bringing back the long pending issue of lack of regulations on e-pharmacies under the existing drug regulations in the country, to the fore. Interestingly, this also comes at a time when the government is in the process of forming regulations for online sales of medicines.
In a notice issued on February 8, the DCGI Dr V G Somani said that his office has received various representations from time to time raising concerns regarding sale of drugs through online, internet or other electronic platforms including various mobile applications, in contravention to the provisions of the Drugs and Cosmetics Act, 1940 and Rules there under and the High Court of Delhi in December 12, 2018, issued an injunction against online sale of medicines without licence.
The notice sought the companies to show cause within two days from the date of issue of the notice, why action shall not be taken against them for sale or stock or exhibit or offer for sale or distribution of drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder.
“In case no reply is received, it will be presumed that you have nothing to say in this matter and necessary action shall be initiated against you without any further notice,” added the notice.
The online sale includes drugs under Schedule H, H1, and X which are only allowed to be sold by retail under a valid prescription of a registered medical practitioner and supplied under the supervision of a registered pharmacist.
The drug regulator said that as per the regulations, the manufacturer for sale or for distribution, or sell, or stock or exhibit or offer for sale or distribute any drug is prohibited except under and in accordance with the conditions of a license issued for such purpose and the Rule 64 of the Drugs Rules, 1945, prescribes conditions to be satisfied before a sale license is granted, while Rule 65 prescribes the conditions of the license to be complied by the licensee. Further, Rule 62 stipulates that, if the drug is sought to be sold or stocked for sale at more than one place, a separate application is to be made to the licensing authority for grant of license.
“Thus, for sale, or stock or exhibit or offer for sale or distribution of any drug, a license is required to be obtained from the concerned State Licensing Authority and conditions of license are required to be complied by the licensee,” says the DCGI’s notice.
The Central drug regulator, following the Delhi High Court’s order in 2018, forwarded it to all State and Union Territory drug controllers, in May and November, 2019, for necessary action and compliance. The order was once again forwarded to the State drug regulators on February 3, 2023, and in spite of this, the online players are found to be engaged in such activities without license, alleges the DCGI.
Such sales activities through online, internet or other electronic platforms including various mobile applications without a license “have potential impact on quality of drugs and pose risk to the public health due to potential misuse of drugs through self-medication, indiscriminate use of the drugs etc.,’ added the DCGI.
It may be noted that the country’s largest pharmaceutical products trader’s body, All India Organisation of Chemists and Druggists (AIOCD) has been opposing the online sales of drugs in the country, alleging that it is a threat to public health. Petitions were filed against online sales, questioning the lack of legal backing for such sales of pharmaceutical products in the country, in Delhi High Court and Madras High Court, among others.
Attempts to reach out to the leaders of some of the major e-pharmacy firms in the country did not elicit response immediately.
Interestingly, the notice comes at a time when the government is in the process of bringing in the New Drugs, Medical Devices and Cosmetics Bill, a draft of which was published in last July, which includes provisions for online pharmacy firms. Industry leaders such as Tata Group, Amazon, Flipkart and others have already invested into the e-pharmacy and online health market, expecting the digital format to have a bright future in the healthcare market in the country.
The minister of state in the ministry of health and family welfare Dr Bharati Pravin Pawar, answering to a question in the Lok Sabha on February 3, 2023, said, “In order to regulate the online sale of medicines comprehensively, the Government of India has published draft rules for inviting comments from public/stakeholders for amendment to 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, etc.,” added the minister.
According to a KPMG-FICCI report in 2022, the e-Pharmacy market in India is expected to grow at a higher compound annual growth rate (CAGR) of around 40-45 per cent in future, backed by the growing internet penetration and digital payments and government support, according to a KPMG-FICCI report.
The e-pharmacy market was valued at $344.8 million in 2021, growing at a robust growth rate of 21.28 per cent CAGR during 2021-2027, with growing internet penetration in the country. Another report said that the segment already has more than 50 players in the country, in 2020.
“It is anticipated that e-pharmacies hold tremendous growth potential and will continue growing in India. Some of the key factors such as growing internet penetration and digital payments infrastructure, rise in industry investments and medicine spending, as well as government initiatives will fuel growth of this sector,” said the KPMG-FICCI report.
The Indian Medical Association (IMA) in a white paper issued in 2022 on online pharmacy, stated that it is against online pharmacies in the country since this will encourage substitution of cheaper and spurious drugs by the online stores and the doctor-patient confidentiality will be affected.
“This will encourage patients to use one prescription repeatedly without the supervision of the Doctor. This can cause many adverse drug related reactions, it will encourage drug abuse and overuse of habit-forming drugs. The medicolegal liability will still fall on the doctor, when a patient misuses this facility,” it said.
The white paper, which observed that there are no well-defined dedicated laws for online pharmacies, alleged that it will promote drug abuse, misuse, self-medication and various other issues.
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