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Indian E-pharma Obstructed With Muddled Regulatory Norms

India’s pharmaceuticals industry is expected to account for about 3.1-3.6 per cent of the global pharma industry by value, and currently accounts for 10 percent by volume

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Online pharmacies emerging in India have met with major concerns regarding the misuse of technology, safety concerns on electronic prescriptions and opposition from offline chemists faced by the industry. The Indian Internet Pharmacy Association (IIPA), is leading the Indian e-pharma players to bring to notice and resolve the roadblocks raised by the regulatory bodies. While the IIPA members strive hard to follow regulations and operate legally, it has taken up as its mission to clarify that it is not the non-adherence of regulations, but the lack of a proper regulatory framework that has become a stumbling block e-pharma startups.

The pharmaceutical business falls under the Drug and Cosmetics Act, 1940. The IPA members have requested the sub-committee created by the 48th Drug Consultative Committee formed in July last year, by Drugs Controller General of India (DCGI), to formulate guidelines on the use of technology in pharma. The committee was expected to submit the report within three months (by October last year), but has not come up with even the draft report yet.

The Maharashtra Food and Drug Administration (FDA) filed an FIR against Mchemist Global Pvt Ltd and has also asked to maintain a strict vigil on all activities conducted by the epharma companies. There are regular probes and raids at office spaces, where employees are frisked and threatened. Mumbai-based Pharmeasy, Delhi-based M-chemist and Mera Medicare in Gujarat had recently faced police investigations and FIRs.

The industry has been losing about 50-60 per cent business because of being stringent with prescriptions and renewing requests. India’s pharmaceuticals industry is expected to account for about 3.1-3.6 per cent of the global pharma industry by value, and currently accounts for 10 percent by volume. (Source: Make in India Statistics) The $18-billion pharma retail market is set to grow to $55 billion by 2020 and is fast coming under the spotlight due to its growth potential in the coming years. Online e-pharma startups in India have already raised $92.6 million in funding so far.

Currently, India has about 45-50 e-pharma startups, major players being 1mg.com, Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com (PM Health & Life Care), SaveOnMedicals and Savemymeds.

Following are the gaps that the E-pharma companies fill:

1. E-pharmas can bring the pharma industry data on systems bringing the entire supply chain online

2. E-pharma tackles the issues of fake medicines, since the entire supply chain is well-documented and trackable.

3. The e-pharmacies have made it mandatory to submit a scanned copy of the prescription, which has been crossed-checked with a local doctor in case found suspicious.

4. For chronic diseases, patients are requested to produce a new prescription in case of the expiry of an old one

5. E-pharma can assist in monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions

6. Doorstep delivery of medicines will make life easy for patients who will not have to rely on others to get their medicines

E-pharmacies are in line with Prime Minister Modi’s vision with Digital India and Startup India campaigns. All these companies, mostly started last year, are at the nascent stage and need support from government. The IPA committee claims to have made all efforts to bring up the issue, and has suggested best practices from around the world to help draw out a framework.