Urgent need to regulate and streamline e-pharmacies

In an order that will force the central government to take a call on the long- pending issue of regulating online pharmacies, the Delhi High Court has recently directed the Centre to report the outcome of consultations and deliberations with the stakeholders related to the five-year-old draft notification for inclusion of rules to regulate online sale of medicines within six weeks apart from its final stand on the issue.

As the country's pharmaceutical trade started gradually moving from offline to online at the turn of last decade, the issue caught the attention of the drug regulators. The Union Health Ministry constituted an expert committee in July 2015, under the chairmanship of the then Maharashtra FDA Commissioner Dr Harshdeep Kamble, to assess the feasibility of online pharmacy in the country. After prolonged deliberations, the ministry on August 28, 2018 came out with an extensive set of draft regulations to amend D&C Rules by incorporating a separate part for regulating online pharmacies. Since then, the issue is entangled in the bureaucratic circles of the ministry.

A new set of rules for e-pharmacy is of much significance as in the absence of clear-cut provisions in the D&C Act regarding the sale of drugs through e-pharmacies, utter confusion prevails in the country's pharmaceutical market at present. The country currently does not have a regulatory mechanism for online sale of drugs and the laws governing the brick-and-mortar pharmacy business are applicable to e-pharmacies as well.

The D&C Act does not distinguish between conventional and online sale of drugs. As per Section 18(c) of D&C Act, 1940 to be read with Rule 65, only a licensed retailer is entitled to sell drugs and that too on producing a doctor’s prescription. Rule 65 stipulates sale of drugs under the supervision of a registered pharmacist which also involves signing of the bill and stamping of the prescription by the pharmacist and the doctor. But, according to reports, as the existing laws are vague on the issue, sale of prescription drugs by the e-pharmacies in contravention to the prevailing laws is rampant.

In the context of the rising incidence of multi-drug resistant bacteria, which is a serious public health issue worldwide, there is a larger public interest in regulating the online supply of drugs. Easy access to critical medicines, like antibiotics, through online pharmacies is a serious issue. It needs stringent and specific provisions to ensure effective monitoring and supervision of online pharmacies. It is a cause for serious concern as, in the absence of clear provisions, the new trading platform can also be used by unscrupulous elements in the trade to route substandard and spurious medicines.

A parliamentary standing committee of the Union Commerce Ministry had last year recommended that the draft of the e-pharmacy rules, which the central government had published in 2018, should be finalised and implemented at the earliest. The Committee, headed by V. Vijayasai Reddy, added that a comprehensive guideline for the e-pharmacy or e-health platforms should be released by the government without further delay. The members of the committee were earlier informed that the scope for e-commerce in the pharmaceutical industry is immense and if properly regulated, online pharmacies in India could benefit various stakeholders. However, there is a serious need for framing the laws within India, as the online pharmacy laws are still in nascent stage and there are no dedicated online pharmacy laws in the country. In the absence of regulatory guidelines, there is always a threat and possibility for supplying illegal, outdated and counterfeit medications.

In fact, the Delhi High Court in its interim order on December 12, 2018 cautioned e-pharmacies against online sale of medicines without licence and had directed the drug regulator to ensure that the same is prohibited forthwith. Despite the court order, online sale of drugs has been going on in the country.

As the issue lingered on, the All India Organization of Chemists and Druggists (AIOCD), on May 29 of this year sent a letter to the Cabinet Secretary, urging him to intervene and ban online pharmacies on the grounds that they are violating norms and putting people's lives at risk. The Centre has to act and get tough.

(The author is freelance journalist with varied experience in different fields)