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E-pharmacy players welcome health ministry's draft rules to facilitate sales of drugs online

Laxmi Yadav, Mumbai
Monday, October 09, 2017, 08:00 Hrs  [IST]

E-pharmacy players have welcomed Union health ministry's draft Drugs (Sale and Distribution) Rules, 2017 aiming at bringing clarity to the operational aspects of functioning of e-pharmacies, ensuring safe, compliant and efficient dispensing of medicines to patients.

Finalization of the drafted rules will be a welcome step and will remove ambiguity on regulations to facilitate online sale of drugs in a safe and secure environment. Hopefully, the final ratification will also bring a level playing field, vis-à-vis the offline stores, said Pradeep Dadha, founder Netmeds.

“A secured functional system for online pharmacies becomes crucial in cases where access to offline pharmacies becomes a challenge, particularly for the aged who cannot personally visit a pharmacy or availability of medicines in remote locations, e-pharmacy is a blessing in disguise offering doorstep delivery of the right medicine as per prescription. Also, for parents whose wards are staying away for professional reasons or education in a different state, e-pharmacies like ours helps with expression of distance-care, ensuring timely delivery of medicines when needed, within the regulatory framework taking in to consideration due validation of the prescription and local operation,” said Dadha.

Welcoming the government’s move towards bringing much-needed changes in the regulations of the sale of medicines, Prashant Tandon, president, 1MG said “There is a need to considerably improve accessibility and affordability to the quality medicines, for which leveraging technology will be critical. The introduction of the electronic portal and newer classification of medicines could bring much-required transparency and traceability in the retail pharmacy sector. However, we have reservations on some aspects of the draft rules since it seems that certain provisions which had been debated at length in earlier conversations have been missed/omitted while drafting the rules.”

“Our fundamental stand has been that same rules should be applicable for every participant in the ecosystem, whether the channel used is online or offline. The principle of equal footing for all channels must be applicable and there cannot be specific onerous requirements on any one channel over the other. However, the draft does suggest different compliance requirement for the digital channel (i.e. e-pharmacies and e-pharmacy marketplaces) vs the brick and mortar retail pharmacies. This defeats the entire premise of the e-portal and also the parity for all channels. The draft also speaks about strange requirements of inspection books and hard copies of e-prescriptions to be maintained, which are backward looking steps that serve no purpose, given the electronic audit trail of all transactions is available if required for inspection. Bureaucratic paperwork is highly unnecessary and against basic principles of ease of business. In fact, for e-pharmacies, we request that there should be no physical visit from inspectors given that all required data can be made available digitally,” he said.

The draft rule also suggest restriction of interstate distribution of the medicines. This clause can, if implemented as stated, will deny access to medicines to smaller towns and geographically remote places. Further, the entire exercise of GST is towards creating India as 'one market', and creating access to all goods, including medicines, to the entire country as one state. Retail pharmacies, online or offline, should not be prevented from serving the entire country, regardless of the geographical location of the patient. A key value of national e-pharmacies is that when medicines are short supply in a state, and available in other states, the e-pharmacies can provide the access. State level restrictions highly unadvisable, said Tandon.

There is also a need for the definitions to be clear and in line with existing provisions of retail. The draft defines “e-pharmacy” in a very broad and general sense, and does not clearly articulate the multiple models of retail, as already well defined by DIPP. We recommend that rules must explicitly provide the definitions of marketplace as well as inventory based models of e-commerce as per the DIPP Press Note No 3 (2016 Series); Ministry of Commerce and Industry, Department of Industrial Policy & Promotion. Many small retailers would like to join a platform to enable them to participate in the e-pharmacy market: they cannot afford to all set up individual portals and the rules should clearly mention the requirements of marketplaces as well as its participating retailers, he stated.

In addition, considering the complexity of implementation of e portal and pragmatically balancing it against the need to ensure adequate access to medicines, we recommend that in the initial phase all pharmacies (online and offline) should be required to upload only information for sensitive drugs belonging to Schedule V and Schedule VI based on the proposed classification system. Also, the e-portal needs to be adopted equally for all pharmacies and we must adopt a practical implementable approach given the current state of pharmacies in India. We recommend starting e-portal adoption with a small set of medicines that are highly sensitive, for all retailers, he opined.

 

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Aishani Das Oct 9, 2017 6:29 PM
Ma'am, I read this article and found it useful for my research purposes. I am a law student, in the final year of her graduation.

Ma'am, I was wondering if you could please help me by providing a link to the draft Drugs (Sale and Distribution) Rules, 2017 that you have mentioned above.

Thank you.
 
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