Internet Pharmacy Rules: Clear Regulatory Guidance Needed

There is a serious need to frame the laws in India as the online pharmacy laws in India are still in their infancy and there are no dedicated online pharmacy laws in India. It is clear that in the absence of regulatory guidelines, there is always a threat and possibility of supplying illegal or unethical drugs or expired, substitute or counterfeit drugs to the person who ordered the drug at the instead of real medicine.

Concerned about the undue delay in finalizing the rules and regulations of the nascent online pharmacy sector to control the online sale of medicines in the country, the Parliamentary Standing Committee of the Ministry of Commerce has recommended to the central government that the draft of the ‘e- The Pharmacy Rules which the Union Health Ministry issued almost four years ago should be finalized and implemented at the earliest. The parliamentary committee, in its report on “Promotion and Regulation of E-Commerce in India”, which was presented to the President of Rajya Sabha on June 15, said that a comprehensive guideline for pharmacy or health platforms online should be released by the government without further delay. Appalled that the draft e-pharmacy rules have yet to be finalized years after a high-level committee was formed for the purpose, the parliamentary committee, chaired by MP V Vijayasai Reddy, reiterated this undue delay in the adoption of a final regulation. will lead to uncertainty that is not conducive to fast-moving digital markets. The Committee, while appreciating the rise of electronic commerce in the pharmaceutical and health sector, expressed concern about the possible misuse of these channels for the distribution of illegal or unethical drugs or of expired, substitute or counterfeit medicines in the absence of regulation. Strict regulation of the e-health and e-pharmacy sector is essential given the potential damage it can cause to the health of the end user if misused.

It is evident that the scope of e-commerce in the pharmaceutical industry is immense and if properly regulated, online pharmacies in India could prove beneficial to various stakeholders. However, there is a serious need to frame the laws in India as the online pharmacy laws in India are still in their infancy and there are no dedicated online pharmacy laws in India. It is clear that in the absence of regulatory guidelines, there is always a threat and possibility of supplying illegal or unethical drugs or expired, substitute or counterfeit drugs to the person who ordered the drug at the instead of real medicine. There are also other concerns, including the potential lack of confidentiality, improper packaging, and consumption of harmful drug interactions, among several other issues. In such a context, a comprehensive guideline that encompasses due diligence measures should be undertaken by online pharmacy platforms; mandatory registration with the competent authority for the sale of drugs should be done, the assignment of responsibility on these platforms for the sale of genuine drugs, the regulation of the sale of controlled drugs, etc. should be formulated in consultation with all stakeholders.

It is now abundantly clear that the national online pharmacy market is brimming with activity with the entry of billionaires like Jeff Bezos and Mukesh Ambani into the nascent sector. And according to available data, the Indian e-pharmacy market, with around 50 e-pharmacies and accounting for 14% of the total e-pharmacy revenue in the Asia-Pacific region in 2020, is expected to grow at a CAGR higher. by around 40-45% compared to global e-pharmacy markets which are expected to grow at a CAGR of around 15-20%. Furthermore, drug expenditure in India is expected to increase by 9-12% over the next five years. But unfortunately, the country does not currently have a regulatory mechanism for the online sale of drugs and the laws governing the physical pharmacy sector also apply to online pharmacies. The Drugs and Cosmetics Act (D&C Act) does not distinguish between the conventional sale and the online sale of drugs. Pursuant to Section 18(c) of the D&C Act of 1940 to be read with Rule 65, only a licensed retailer is permitted to sell drugs and that too on the basis of a doctor’s prescription only. Rule 65 stipulates the sale of drugs under the supervision of a licensed pharmacist, which also involves the signature of the invoice and the stamp of the prescription by the pharmacist and the doctor.

But, according to reports, as the existing laws are vague on the matter, there is a rampant sale of prescription drugs by online pharmacies in violation of the country’s existing laws. In the current circumstances of the Covid-19 pandemic, when the government and the medical fraternity have asked people to stay indoors, the relevance of online pharmacy is much greater. But, in the absence of clear provisions in the D&C Act regarding the sale of drugs through online pharmacies, complete confusion reigns in the country’s pharmaceutical market, which has resulted in a verbal duel between the associations of offline pharmacies and on line. This scenario should end. The government should waste no more time finalizing proprietary rules for the nascent online pharmacy industry in India.

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

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