By Vikram Narula and Rupin Chopra
Amendments pertaining the sale of medicines & drugs in India
The Government of India had published draft rules and invited comments/suggestions from the consumers/stakeholders for amending the Drug and Cosmetic Rules, 1945. The purpose of the amendment was to regulate the online sale of medicines and drugs. This move will be extremely beneficial for consumers to purchase genuine medicines from reliable web portals. This initiative will also result in moving a step closer towards the achievement of success of the Digital India program.
This initiative was trapped up in a legal tussle with several organizations which represented chemists and pharmacists having filed petitions across various courts in the country as they were against the concept of e-pharmacies. Chemists and pharmacists have been opposing the initiative of regulating the online sale of medicines as they are of the view that easy availability of drugs and medicines may lead to their misuse.
The draft rules prescribe that no person will be eligible to sell, distribute or offer to sell drugs through an e-pharmacy unless such person is registered with the applicable authority. The Government of India in the draft rules envisioned that the details of the patient will be kept confidential and will not be disclosed to any person other than the Central Government or the concerned state Government. It will be pertinent to mention that the registrant of the e-pharmacy will be required to apply for registration with the Central Licensing Authority. The application for registration will be required to be accompanied with a sum of INR 50,000.
At present there is no mechanism to verify whether the medical prescription submitted to an online pharmacy is genuine. Hence, there is a yawning gap in the Statute addressing the issue of sale of medicines online and patchwork of filling to make the Statute effective and workable in this cyber age is need of the hour. Resultantly, such transactions are many a times prone to fraud. In the United States of America, most prescriptions which are issued by the physicians are e-prescriptions and are issued directly to e-pharmacies though electronic transmissions.
The All India Organization of Chemists and Druggists had requested that an e-prescription be shared with stakeholders before the issuing of the final rules. Presently, online pharmacies operating in India are operating in an unregulated manner owing to the conflicting orders of various courts in the country. The final rules are expected to provide clarity to this sector.
It is anticipated that the growth in the popularity of e-pharmacies will hamper the growth of brick and mortar stores. The rapid increase in the competition will hamper the growth of offline stores and will change the pharmaceutical market radically. Therefore, the Government of India will be required to ensure that the regulations are in place to protect the interest of offline stores as well.
The United States of America in this regard requires all online pharmacies to have an offline presence as well. Although this enhances the credibility of online pharmacies but currently many of the smaller online pharmacies in India do not have the funds to establish an offline set-up. This may lead to the growth of fake e-pharmacies. Hence, there is a requirement for a stringent law for regulating online pharmacies in India and it is almost important to ensure that there is an effective enforcement of the regulations that govern e-pharmacies.
It is essential to inform consumers about the safe practices for purchasing medicines from e-pharmacies. In the United States of America, a list of approved online pharmacies is available for consumers. The pharmacy domain is also a good way to ensure whether an online pharmacy is genuine or not.
The amendment of the Drugs and Cosmetic Rules, 1945 also requires e-pharmacies to maintain confidentiality of the details of patients. These amendments are in sync with the provisions of the Information Technology Act, 2000 as well as the Personal Data Protection Bill, 2018. It is essential to mention that e-pharmacies are obligated to disclose information to Central/ State Government as and when required for the purpose of public health. The relevant extract of Rule 67K of the draft rules for amending the Drugs and Cosmetic Rules, 1945 are mentioned below:
Rule 67K – Disclosure of information generated through e-pharmacy portal
(1) the information received by e-pharmacy registration holder from the customer by way of a prescription or in any other manner shall not be disclosed by the e-pharmacy registration holder for any other purposes not shall the same be disclosed to any other person.
(2) the e-pharmacy registration holder shall be duty bound to provide such information to the Central Government or State Government, as the case may be, as and when required for public health purposes.
(3) the e-pharmacy portal shall be established in India through which they are conducting the business of e-pharmacy and shall keep the data generated localized:
Provided that in no case the data generated or mirrored through e-pharmacy portal shall be sent or stored, by any means, outside India.
It is expected that the release of the final rules will provide a boost to e-pharmacies and also permit them to function on the same level as physical chemists and pharmacists. The final rules are likely to be issued in December 2019.