Centre puts onus on SLAs to take action against e-pharmacies for violation of D&C Act and Rules
With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.
While the ministry of health and family welfare (MoHFW) in the previous session of the Parliament in February, 2023, said that the government has published draft rules to regulate the online sale of medicines comprehensively, it did not mention the effort on forming the regulation in its latest reply.
To a question raised by Member of Parliament, Shanta Chhetri, in the Rajya Sabha recently, on the details of laws governing e-pharmacies especially in relation to drug regulation and the government’s stand on the issue, Dr Bharati Pravin Pawar, minister of state in the MoHFW, said, “Sale of drugs in the country is regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 by the State Licensing Authorities through a system of licensing and inspection. SLAs are legally empowered to take stringent action against violation of provisions of the Act and Rules”.
Responding to the question on March 14, the minister also informed that the chemist association had given advance notice of nation-wide agitation against the sale of drugs on the internet, from mid February.
It may be noted that there are no clear provisions related to online sale of drugs in the Drugs & Cosmetics Act, 1940 and Rules, 1945 and this has led to several legal disputes regarding the legality of e-pharmacies and their operations in the country in the last few years.
The All India Organisation of Chemists and Druggists (AIOCD), the largest organisation of chemists and druggists in the country, has earlier declared the agitation against the online pharmacies alleging that they are illegal and are a threat to public health. However, the call for agitation was withdrawn following a positive response from the ministry regarding their demands.
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.
In February, the then DCGI V G Somani has issued a show cause notice to various online pharmacies including Tata 1mg, Amazon and Flipkart among others seeking their explanation not to take action against selling drugs online in contravention to the provisions of the Drugs & Cosmetics Act, 1940 and Rules thereunder and the High Court of Delhi’s injunction order against online sales of medicines without license in December, 2018. The notice sought the online players to show cause in two day’s time, but soon after the letter, the Ministry replaced Somani, who was on an extension in the post, with another official temporarily.
Interestingly, the government’s stand 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.
Dr 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.
However, the demand from AIOCD to shut the online drug business model in the country 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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