Regulation on online pharmacy businesses and e-commerce portals in India

online pharmacy businesses

The Union health ministry is close to giving final touches on framing a policy on the use of information technology in online pharmacy by launching a centralised portal to help make use of technology for making medicines available in a regulated and feasible manner.

CDSCO is in consultation with Department of Pharmaceuticals, Law Ministry and Commerce Ministry to develop a centralised online system and will involve manufacturers and supply chain managers to develop a fool-proof system.

Online pharmacy is currently governed by Information Technology (IT) Act, 2000 and Drugs and Cosmetics Act, 1940 but recommendations from all stakeholder have been sought on the broad contours of a policy that will also ensure a level playing field for online pharmacies vis-a-vis traditional retailers.

Drug Consultative Committee had met on November 6, 2016 and accepted the much awaited recommendations of a select group of state drug regulators on online pharmacy under the chairmanship of outgoing Maharashtra Food and Drug Administration (FDA) Commissioner Dr Harshadeep Kamble.

This according to DCGI Dr G N Singh will involve building capacities wherein new technology can become useful and feasible with out disturbing the existing systems followed by a clear-cut policy on regulating online pharmacies.

The drug consultative committee under the Union health ministry had last year deliberated on aspects related to information technology which can be aligned with the drug regulations existing currently to suit patient needs among other major pain points.

Guidelines on the same had been submitted 8 months ago by the sub-committee set up by the 48th Drug Consultative Committee under the chairmanship of Maharashtra FDA Commissioner. The sub-committee had taken representations and views from the concerned stakeholders for a comprehensive online policy which will mark a positive step towards formulating a policy and subsequent release of a set of guidelines on the use of information technology in online pharmacy and authorise its legal validity.

In most countries, the legitimate online pharmacies are given specific operating licenses that are shared with consumers to fight the menace of cross border internet pharmacies.

Online businesses and e-commerce portals must take appropriate steps to avoid making infringing/counterfeit products available for sale on their portals. They should establish very clear and well defined take down policies and processes to defend themselves from infringement actions. The terms and conditions with vendors must include clauses addressing third party IP infringement.

In order to curb online sale of drugs by e-commerce firms, the Bombay High Court has asked the state drug regulatory agencies as to how they intend to tackle the violations and subsequent action they would take on the same. Following this, the Maharashtra Food and Drug Administration (FDA) has started a special drive to keep a tab on the illegal online sale of drugs by unregistered firms and has deputed a team of drug inspectors to implement the same.The Drug Controller General of India (DCGI) had earlier directed all the state/UT drugs controllers to keep a strict watch on online sale of drugs and take action if there is violation of the Drugs and Cosmetics Act and Rules.

Meanwhile, Maharashtra FDA Commissioner has also maintained that online pharmacies can sell only OTC drugs and not prescription drugs until the policy on the same is framed.

A group of online pharmacies in the country under the aegis of the Indian Internet Pharmacy Association (IIPA) had in the past urged the DCGI constituted sub-committee formed under the chairmanship of Maharashtra FDA Commissioner Dr Harshdeep Kamble on online pharmacy to help set up a registry of online pharmacies to ensure clarity on the legitimate players and frame interim guidelines.

IIPA is a group of online pharmacies represented by 1mg.com, Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com, SaveOnMedicals and Savemymeds.

IIPA has pinpointed that there are multiple online pharmacies operating from different parts of the world that need to be monitored. This according to them will enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.

Once again, India’s pharmaceutical trade is in an agitation mood. This time also, the trade has some serious issues which should not be ignored. The All India Organization of Chemists & Druggists had called for a nationwide strike on May 30 to protest against the health ministry's proposals to regulate sales of drugs through e-portal and allow online trade in pharmaceutical products.

The trade body had already sent a representation to the Union health ministry seeking a rollback of the draft notification seeking to implement an e-platform for the pharma trade on March 16. It has not received any positive response from the ministry as yet. As per the draft notification, all pharma companies will be required to register themselves with the e-portal and enter data relating to sale of drugs on the e-platform to distributors, stockists and wholesalers with batch number, quantity supplied and expiry date of the batch. All stockists and wholesalers will be required to enter details of stocks received and supplied by them to distributors or retailers.

The move to legalize online trading of pharmaceutical products is another disturbing issue the trade has been objecting to for some time now. It is a fact that with the commencement of operations of some of the large online pharmacies have already affected the viability of several thousands of chemists across the country.

With these two proposed reforms, the worst affected segment will be the pharmaceutical trade as most of the operators in this trade are the people with limited financial capability and technical expertise. According to AIOCD, the plan to set up the e-portal to regulate sale of medicines is totally unfeasible on account of various reasons. Considering the insufficient IT infrastructure across the country, it will be difficult for most of the stockists and chemists to upload the details of the sales on the e-portal within a stipulated period.

The retail chemists located in rural or remote areas need to upload data either through mobile phones or through internet at least once in every fortnight. No retailer shall be permitted to sell any medicine unless such pharmacy is registered on the e-portal. And creation of e-portal to monitor sale of drugs without adequate regulatory machinery for recording the medicines manufactured in the country and their supplies to the stockiest and sale of medicines to the customers will not bring the desired result. In case of allowing internet sales of medicines throughout the country too, there are serious regulatory issues to be addressed by the health ministry. Currently, drug sale is regulated by state licensing authorities whereas the online sale of medicines is proposed to be registered with central drug control authority.

This can create chaos and lack of coordination between the central and state licensing authorities especially when there is already a shortage of drug inspectors and poor infrastructure facilities in the country. Considering these practical problems, it will be prudent on the part of the health ministry to have detailed deliberations with the trade, pharmaceutical industry and medical experts before rushing with these reforms.

 

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