Now the government plans to take its work on the draft forward, likely in next few weeks, The Indian Express has learnt. Now the government plans to take its work on the draft forward, likely in next few weeks, The Indian Express has learnt.

With the Narendra Modi government back to power for another 5-year term, authorities handling pharmaceuticals and healthcare have a backlog of policies and regulations to pass and implement.

Going by the re-elected government’s track record over the past five years, the health services industry may also have to gear up for more price control on medicines. In February, the country’s drug pricing watchdog, the National Pharmaceuticals Pricing Authority (NPPA), capped trade margins of 42 cancer medicines at 30 per cent— a move it expected would drop maximum retail prices (MRPs) of over 100 brands by up to 85 per cent and provide over Rs 100 crore in savings for cancer patients.

The move is a “proof-of-concept” for the regulator to implement a system of trade margin rationalisation across medicine segments and the results of the pilot will be released to the public “soon”, a senior NPPA official told The Indian Express. It is likely that expanding such price control may be on the 100-day agenda of the re-elected government, however this has not been communicated to NPPA, said the official.

Another area of focus might be the implementation of the health ministry’s regulations for online pharmacy players, which had been in the works since 2016 but was stalled close to the Lok Sabha elections. Senior health ministry officials earlier said inter-ministerial consultations had been initiated on latest draft, leading to the delay. Some officials had also said that the government was still looking into the public feedback received on the draft, which would allow regulation of India’s nascent e-pharmacy industry.

Now the government plans to take its work on the draft forward, likely in next few weeks, The Indian Express has learnt. As per industry estimates, online pharmacies account for around 1 per cent of India’s over 1 lakh crore medicines retail industry, but was estimated in 2016 by the Federation of Indian Chambers of Commerce and Industry to have potential to account for 5-15 per cent of total sales.

The move to recognise and regulate e-pharmacies in India had been strongly opposed by the country’s brick-and-mortar chemists, which have conducted strikes and gone to court over the last three years claiming safety and legal issues with the online model. Coincidentally, chemists make up over eight lakh of the country’s voter base, but it is not confirmed whether this played a role in the delay of the draft.

A proposal to allow patients to seek compensation for faulty medical devices—a highly scrutinised industry following government and media investigations into the adverse impacts of certain hip implants by US giant Johnson & Johnson—is also yet to fructify. The proposal to amend the 2017 Medical Devices Rules to include a provision for compensation in the event of adverse reactions or death due to medical devices was brought up during a Drugs Technical Advisory Board (DTAB) meeting in November 2018.

According to minutes of DTAB’s meeting, a 10-member sub-committee was formed to look into the matter and provide further recommendations, but no deadline was set. Currently, there is “no provision” for compensations in such a scenario, which has led to a legal battle over a formula that a Central Drugs Standard Control Organisation (CDSCO) committee has used to decide how much J&J has to compensate patients affected by its ASR implants. Persons close to the development told The Indian Express that the sub-committee’s work on this proposal was “in progress” and may be concluded in another three months. Considering the timeline, it is not clear whether this proposal, which would make companies financially liable for problems with their devices, is a part of the health ministry’s 100-day agenda.

Queries to health secretary Preeti Sudan remained unanswered by press time Tuesday.

Further into the current government’s tenure, industry experts also expect increased focus on reducing prices of more medical devices after the success that the Modi-government has advertised from price caps on stents and knee implants. Progress on reducing India’s dependence on China for its supply of key ingredients for medicines—an ongoing concern for the industry to mitigate any medicine shortages and price rises—is also required, some feel.

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