e-pharmacies informed CDSCO they are only providing online platform connecting users & pharmacies: Minister
The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this year.
While it also mentioned the draft rules related to online sale of medicines released almost five years back, the Ministry did not comment on the current status of the draft or any other plans regarding the online drug sales in the country.
The Union Minister of state for health and family welfare, Prof S P Baghel in a written reply in the Rajya Sabha said that the CDSCO has issued show-cause notices to various firms engaged in online/internet sale of Drugs on 8th & 9th February 2023.
The firms have mostly responded by stating that they are only providing an online platform for facilitating the sale of pharmaceutical products to customers and the platform operates solely as intermediaries, connecting the users and the licensed pharmacies.
The Minister said that in order to regulate the online sale of medicines comprehensively, the Government had published draft Rules vide G.S.R. 817 (E) dated August 28, 2018 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.
However, the reply did not clarify the current status of this draft regulation.
The Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi, in a circular issued on March 9, directed all the States and Union Territory drugs controllers and the Pharmacy Council of India that strict implementation of the relevant sections and rules of the Pharmacy Act, 1947 and Drugs & Cosmetics Act, 1945, has to be ensured.
The DCGI’s communication was with reference to a letter from the Indian Pharmaceutical Association (IPA) seeking strict implementation of Section 42 (a) of Pharmacy Act and the Rule 65 of the Drugs & Cosmetics Act, 1945, against the dispensing of medicines online.
The drug regulator requested the SLAs to ensure that pharmacists are physically present in the retail pharmacies/medical stores and that medicines are sold/dispensed under their direct supervision and to ensure that no prescription medicine is sold/dispensed from the retail medicines shop without a proper and valid prescription.
The Section 42 of the Pharmacy Act recommends that the State government shall notify that no person other than a registered pharmacist shall compound, prepare, mix or dispense any medicine on the prescription of a medical practitioner and whoever contravenes this provision shall be punishable with imprisonment or with fine. The Rule 65 under the Drugs & Cosmetics Act stipulates various conditions of licences for sale of drugs including that the supply of drugs other than wholesale dealing has to be made only under the provisional supervision of a registered pharmacist, among others.
It may be noted that the nation’s largest pharma trade organisation, the All India Organisation of Chemists and Druggists (AIOCD), has been raising objection against allowing e-pharmacies to operate in the country, as it is against the current regulations and could allegedly lead to sales of spurious drugs, among others.
AIOCD’s point of view has many supporters including the Pharmacy Council of India president Montu M Patel. Soon after he took over as the President, Patel said that online pharmacies are illegal in India and the Council has formulated a committee to fight against the e-pharmacies and submitted representation to the government against the business model. He also alleged that high levels of unemployment will occur if e-pharmacies strengthen their operations in the country.
The Indian Medical Association (IMA) in a white paper issued in 2022 on online pharmacy, stated that the Association 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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