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Have you been getting your medicines online? It’s simple. Log in. Upload your prescription, select and pay, and the medicines reach you at your doorstep. For thousands of Indians, specially the elderly, the e-pharmacy business was a godsend. There was just one problem. The e-pharmacy business boomed without any regulation.
On December 12th, the Delhi High Court put a stop to online sale of medicines across India. The order was in response to a PIL filed by a Delhi-based dermatologist Dr Zaheer Ahmed who said that unregulated sale of medicines online will lead to substandard drugs being sold, some of which have psychotrphic substances that can be misused for criminal activities. The PIL also trained guns at the government saying it failed in its responsibility to protect public health which is its Constitutional obligation under Article 21.
What does the order mean for the E-Pharmacies, and for you, the patient?
While the Indian pharma retail market is valued at Rs 1000 billion, the E-Pharmacy business currently is about Rs 3,500 crore and expected to increase to Rs 25,000 crore in the next 3-4 years, according to S Eswara Reddy, Drugs Controller General of India. According to various estimates, there are around 250 online pharmacies in India and the model works on two levels - Business to Customer (B2C) and direct retail platform. They offer heavy discounts, door step deliveries and other benefits that consumers have welcomed.
Currently, none.
Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rule, 1945, and the Pharmacy Act, 1948, govern the Indian Pharmacy Laws. Since they were made before the advent of e-commerce, they don’t cover E-Pharmacy.
In the absence of any laws, in Nov 2016, Federation of Indian Chambers of Commerce and Industry (FICCI) came up with their own “Self-Regulation Code of Conduct for the E Pharmacy Sector,” to ensure patient safety.
Under the code, there was prohibition of sale of Schedule X and other habit forming drugs, and a requirement to partner with the government if any recall of medicines happens. Most online pharmacies require the prescription to be uploaded and
But as the name suggests, it’s self-regulation, meaning it is not enforceable.
Not Quite.
In September 2018, the new draft guidelines to govern E-Pharmacies were put together and the final regulation will be in place as early as end of the year, according to this report.
The Economic Times quoted DCGI S Eswara Reddy, as saying that the final regulations will come into effect by January this year. According to the draft guidelines, no person will distribute or sell, stock, exhibit or offer for sale of drugs through online portal unless they are registered. Sale of tranquillisers, psychotropic drugs, narcotics and habit forming drugs will be prohibited through E-Pharmacies.
But realising that E-Pharmacies play an important role in distribution of drugs, the rules make registration easier. E-Pharmacies will have to registered with the Central Drug Standard Control Organisation (CDSCO), the apex drug controller body in India and central licensing Authority. They can register through any one state for sale across the country. But state governments have the power to cancel registrations if they don’t meet the standards of care and patient safety.
The registration will have to be renewed every three years.
No portal will advertize specific drugs through any media platform.
All India Organisation of Chemists and Druggists (AIOCD), with over 800,000 traditional medical shops under it, have raised their voice against E-Pharmacies, reports Quartz. They say it will be difficult to control sale of contaminated, stale and fake drugs through these portals.
Infact, the Madras High Court had also issued an interim ban on the online sale of drugs. Other states including Maharashtra and Karnataka have come down heavily on E-Pharmacies previously.
The online pharmacies say they are awaiting the order details. There is likely to be distruption. If the new rules do come in place in January, it will take time for these companies to work the formalities. In the meantime, keep your local pharmacist’s number handy.
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Published: 13 Dec 2018,12:26 PM IST