31/10/2018
Madras HC stays Online Sale of Medicines, Drugs through E-Pharmacies
The Madras High Court has granted an injunction restraining the sale of medicines and drugs online, on a plea moved by the Tamil Nadu Chemists and Druggists Association (TNCDA).
The injunction granted by Justice R Mahadevan will be applicable throughout India. Senior advocate ARL Sundersan appeared on behalf of TNCDA. Additional Solicitor General, R Rajagopalan has been asked to get instructions from the Centre on the issue.
The TNCDA had prayed for an injunction of such sale, given that the same is carried out in violation of the Drugs and Cosmetics Act, 1940 and its 1945 rules. As pointed out in their petition, these laws were written prior to the arrival of computers. These laws do not even permit the shipping, mailing or door-to-door delivery of prescribed medicines. Presently, India does not have any concrete laws defined for the online sale of medicines.
Nevertheless, the petition highlights that there are over 3500 sites which sell medicines and drugs online. Such unregulated sale of medicines from unlicensed online stores and e-pharmacies could involve the sale of fake, expired, contaminated, substandard quality, unapproved drugs or otherwise unsafe products that are dangerous to patients and may put their health at risk.
As noted in the petition,
“… medicines are not simple items of commerce, they are an essential component of patient’s health and they must be administrated to patients in a timely manner as prescribed by the Registered Medical Practitioner and such drugs are provided under the direct supervision of qualified person (Pharmacist) for the benefit of patients…The medicines are issued only as per specific prescription and dosages as prescribed by Registered Medical Practitioner. The retail chemist or consumer has no choice to substitute any other medicine or strength of the prescribed medicine.“
It is also argued that online sale or medicines and e-pharmacies are not required in India either, since there are over 8 lakh licensed pharmacies to cater to all the medicinal needs of patients in the country, at affordable, government-notified prices. However,
“If government of India is seriously thinking to permit the online pharmacies, it should be ensured that the medicines sold online are safe, effective and confirm to the quality standards specified in the Act and rules. “
Raising these concerns, the TNCDA had also made representations to concerned government authorities, including the Central Drugs Standards Control Organisation, in 2015.
In 2018, the Central Government introduced draft rules to amend the Drugs and Cosmetics laws to allow licensed E-Pharmacies. The TNCDA had sent their objections to the same, and is pending consideration. The 2018 amendment is yet to be notified.
A similar plea moved by the TNCDA in 2016, calling for blocking websites which sell medicines online, is still pending before the High Court.
In view of the continuing unregulated sale of medicines online, the TNCDA has preferred the instant plea. Among the suggestions made to protect consumer health, is the creation of a special division in the Drug Control Department to regulate licensed E-pharmacies, if they are permitted.
Further, the petition prays that such E-pharmacies should ensure that the relevant prescription by a Registered Medical Practitioner is uploaded online, besides having a certified pharmacist available for customer questions.
The TNCDA has also called for the amendment of Drug and Cosmetics law to ensure that online sale of medicines is safe and secure for consumers, and to safeguard privacy and health information. Moreover, it also recommends that the Government should sensitize the public about the dangers of buying online medicines.
Similar pleas are also pending before the Delhi High Court.
