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IPA’s letter to DCGI: Online pharmacies in contravention of the Pharmacy Act

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Earlier this month, the Indian Pharmacist Association (IPA) wrote to the Drugs Controller General of India (DCGI) opposing online pharmacies in India. The DCGI earlier this month appointed industry body FICCI to as the nodal agency to consolidate and frame guidelines for online sales of medicines through e-commerce channels.

In its letter, obtained by MediaNama, the IPA outlines some of the issues for the proposal for online pharmacies. The IPA’s chief concern is that online pharmacies are in contravention of the Drugs and Cosmetics Act which states that drugs should be dispensed by registered pharmacists. Some of the concerns raised by the IPA include:

– As per Section 42 of Pharmacy Act “Only Pharmacist can dispense medicine on the prescription of a doctor.” And whoever contravenes these provision is punishable with imprisonment.

– There are insufficient numbers of Drug Inspectors in Drug Control Department and it will not be easy to monitor each and every online pharmacy.

–  As per Schedule P of Drugs and Cosmetic Act, no medicine should be stored at a temperature exceeding 30 degree. Storing medicine above the prescribed temperature make medicines ineffective.

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– In the absence of a registered pharmacist at online pharmacy wrong medicine may be dispatched to patient and it may cost the life of patients.

– There is strong possibility that fake, misbranded, adulterated, counterfeit medicine will be sold through online pharmacies.

– There will be a deficit of 5% to 12.5% value added tax to the government and that there will be evasion of taxes by online pharmacies.

Our Take: One of the issues that the IPA has not addressed is the marketplace model. Does the online marketplace need to be a registered pharmacist or if it is okay if the merchants are registered pharmacists? It’s worth noting that 1mg operates as an online marketplace for medicine and offers price comparison and cheaper substitutes among exact formulations for the same medicine. It asks users to submit prescriptions for prescriptions drugs. It claims to have qualified pharmacists on board who provide relevant info about medicines by scanning products. It remains to be seen whether this business model will work according to the DCGI’s guidelines and at the same time allay the concerns of pharmacist associations. 

US FDA advisory

The letter also cited an advisory from the US Food and Drugs Administration warning consumers of the possible dangers of buying medicine over the Internet:

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There are many websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines. But there are also many “rogue websites” that offer to sell potentially dangerous drugs that have not been checked for safety or effectiveness. Though a rogue site may look professional and legitimate, it could actually be an illegal operation. These rogue sites often sell unapproved drugs, drugs that contain the wrong active ingredient, drugs that may contain too much or too little of the active ingredient, or drugs that contain dangerous ingredients.

For example, FDA purchased and analyzed several products that were represented online as Tamiflu (oseltamivir). One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets. When analyzed by FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir.

The letter also mentions that the National Association of Boards of Pharmacy (NABP), the professional organization that represents the state boards of pharmacy in the United States, found that only 4% of online websites reviewed appear to meet state and federal pharmacy laws.

Crackdown in India 

It’s worth remembering that in May the Maharashtra’s Food and Drug Administration (FDA)filed an FIR against Snapdeal CEO Kunal Bahl and the company’s directors for selling prescription drugs on the e-commerce. Snapdeal was reportedly selling sildenafil citrate tablets (Viagra), that only urologists, psychiatrists, endocrinologists and dermatologists can prescribe. In addition the marketplace was also selling OTC emergency contraceptives. Currently, the company has removed all listings of products even remotely related to health & medicines. See here, here, here and here.

In the same month the Gujarat FDA also raided Prowisor Pharma, a  Surat-based online pharmacy that was reportedly selling drugs worth Rs.7 lakh online.

Image source: Flickr user ep_jhu

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