Thursday, February 29, 2024

Warning Label

Recently, the Delhi High Court gave the centre a last chance to frame the policy on online sale of medicines in the country, failing which the concerned joint secretary of the government will have to appear before the Court on the next date of hearing on March 4, 2024.

The Court gave the centre eight weeks time to come up with a policy. The order was passed by the Division Bench of Acting Chief Justice Manmohan and Justice Mini Pushkarna on a batch of petitions seeking a ban on the illegal sale of drugs online.

The petitioners also challenged the draft rules published by the Union Ministry of Health and Family Welfare to further amend the Drugs and Cosmetics Rules. Noting that the matter has been pending before the Court for five years, the Bench observed that the Union of India had sufficient time to frame the said policy.

The Bench recorded in its order the submissions made by central government’s standing counsel Kirtiman Singh, who said that consultations and deliberations were still going on with the draft notification, dated August 28, 2018, related to the online sale of drugs. 

The Court had earlier directed the centre and the Delhi government to take necessary action in respect of persons engaging in online sale of drugs without a valid license. It had passed an order in December 2018, stopping the sale of drugs online since the same was not permitted under the Drugs and Cosmetics Act, 1940, and the Pharmacy Act, 1948. 

An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the internet and sends orders to customers through mail, shipping companies, or online pharmacy web portals. Since the conception of e-pharmacies in India, the mode of giving online orders, receiving orders as well as timely delivery has resulted in increased demand in this sector.

The Court in the recent hearing was responding to a batch of petitions, including a PIL filed by a Delhi-based dermatologist Zaheer Ahmed, seeking a ban on the “illegal” sale of drugs and medicines online. The Court passed its recent order in response to his PIL. 

Ahmed in his plea contended that the “illegal” sale of medicines over the internet could lead to drug abuse and addiction to drugs. He also submitted that easy availability of drugs online, without any checks on e-pharmacies, puts the health and life of people at great risk, and affects their right to a safe and healthy life under Article 21 of the Constitution.

After the draft rules were published, various petitions were filed in the Delhi High Court and Madras High Court seeking a ban on all e-pharmacy operations due to public safety. Later, the Madras High Court pronounced a decision temporarily banning the online sale of drugs and also directed the government to notify the regulations by January 31, 2019, on a petition filed by Tamil Nadu Chemists and Druggists Association, which was later extended to July 31, 2019. 

Further, in an official letter, dated November 28, 2019, the Drugs Controller General of India issued a notification to all drug controllers to enforce an order given by the Delhi High Court in December 2018 in the case of Zaheer Ahmed vs Union of India which prohibited the online sales of medicines without a valid license.

The letter is the latest progress on the development of e-pharmacy policy and regulation in India, which seems to be reconfirming the existing position that online sale should not be done by the pharmacies who do not have a valid license. 

The contempt petition filed in the Delhi High Court sought action against the e-pharmacies for continuing to sell drugs online. It further sought action against the Union government for not taking any action against defaulting e-pharmacies despite the Court’s orders. 

The e-pharmacies, on the other hand, apprised the Court that they did not require a licence for online sale of drugs and prescription medicines because they were only delivering the medications, like food is delivered through food delivery apps such as Swiggy.

There are no dedicated online pharmacy laws in India. The Information Technology Act, 2000, governs some of the legal issues pertaining to online dealings, but it is silent on the aspect of online pharmacy. As a result, illegal online pharmacies have been increasing in India. Though, there is no universal classification for models of online pharmacy based on the current practice, it is usually characterized into organized and non-organized systems. While, the organized system confirms the prescription, maintains electronic records and gives advisory to patients about the side effects and dosage information, the non-organized system does not have such facility and has legal and auditing issues for providing such services.

In India, the regulatory provisions for the manufacture and sale of medicines are covered under the Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; Pharmacy Act, 1948; Information Technology Act, 2000; Indian Medical Act, 1956; Code of Ethics Regulations, 2002; Narcotic Drug and Psychotropic Substances Act, 1985; and Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.

Moreover, the apex drug regulator, Central Drugs Standard Control Organization (CDSCO), has been working on an integrated IT platform to bring in transparency and uniformity in all its processes to track products right from the stage of procuring raw material to supply chain, and finally patterns of consumption categorised by quantity, area, and season.

The government is also working on a unified digital portal that will bring together all stakeholders—regulators, manufacturers, distributors, state-run departments and procurement agencies. The portal will create provisions to capture information from various stakeholders routinely “similar to ITR returns and GST filing”. Once the portal is operational, all other portals used by drug regulators will be discontinued. The portal will become a single window for all drug regulatory activities. The government has called for software service providers to develop the system.

This will integrate the existing information technology portal of the CDSCO, the Sugam portal, all central drug laboratories, state drug controllers and manufacturers. The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have entrusted various responsibilities to the central and state government regulators for the regulation of drugs and cosmetics aimed at ensuring the safety, rights and well-being of the patients.

CDSCO is the primary regulatory body for medical devices in India. It is responsible for overseeing the import, manufacture, sale and distribution of medical devices in the country. It ensures that medical devices comply with safety, quality and efficacy standards. Upon approval of a manufacturer’s MD-14 application, CDSCO issues an MD-15 import license according to the manufacturing site with the approved products listed on it. Therefore, if manufacturers use multiple manufacturing sites, an MD-15 for each site will be needed. In order to sell a medical device in India, manufacturers must obtain a MD-15 import license from CDSCO. 

CDSCO also conducts inspections and audits to ensure that medical device companies are complying with regulations related to safety, quality and efficacy. It also provides guidance on the approval process and requirements for specific product categories.

As the regulatory body for medical devices in India, CDSCO plays a critical role in ensuring the safety and efficacy of medical devices sold in India. Medical device companies must comply with the CDSCO’s regulations in order to successfully enter and operate in the Indian market. CDSCO has been striving to bring transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in India.

The online market for such products is becoming a more serious issue. 

—By Adarsh Kumar and India Legal Bureau


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