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Nandita Vijay, Bengaluru May 27 , 2019
India needs to align with global good practices to reinvogorate its capability in pharmaceutical manufacture. The regulatory authority in the country came up with several new regulations enabling the industry to be able to produce the required high quality drugs for exports. Pharma companies too are increasingly looking to align with the best practices in the world. Moreover, Indian drug manufacturers have motivated countries in emerging markets of Asia, Africa and Latin America to build capability and capacity, stated experts.

At the day-long event organised by Pharmexcil to deliberate and discuss on the 'Recent advancements in the regulatory landscape of the emerging markets', Raghuveer Kini, executive director, Pharmexcil said that the Indian pharma garnered revenues to the tune of US$ 19.3 billion from exports in the year 2018-19. The Pharmexcil has been providing the much needed support along with the Union government’s slew of financial assistance for companies to initiate their export forays. With the barcodes made mandatory, medicines manufactured in India for the world will now have a mark of quality and affordability in the stringent global market.

India needs to have a standard for approval for exports across emerging markets. The Indian Pharmacopeia should be an accepted benchmark for drug clearances across the emerging markets. This will do away from the separate set of data to be submitted for domestic and international markets that is currently in practice, said Sunil Attavar, president, Karnataka Drugs and the Pharmaceutical Manufacturers Association.

According to Amaresh Tumbagi, Karnataka drugs controller, e-governance is the only way forward to speed up approval process for drugs and registration in other countries.

Arun Mishra, executive vice president, regulatory affairs, Indian Sub Continent, GSK, in his presentation on ‘Living Quality- Measuring Pulse: Focus on Behaviour and Culture' pointed out that India has made a mark in the global markets and there are many countries looking at making it big. For example last month, Bangladesh’s pre- accession of application was received by the PIC/S Committee. Similarly, China which dominates in API manufacture has already made considerable in-roads into formulations development. Now India needs to be mindful of the fact there is competition brewing for it.

Our industry has inspired many countries in Asia, Africa and Latin America to get into this business by building both capability and capacity. In terms of the former, our scientific strength, skills sets and technical expertise is not seen anywhere in the world. Similarly in terms of production plants, India is home to the large base of globally approved units. Now taking a cue from Indian talent in pharma, many countries are changing their curriculum. So we should be heedful that our academic programmes are globally relevant.

Stating that there was a paradigm shift in healthcare on understanding the disease and prescribing targeted therapy, Mishra said that India too need to realise that there is decentralisation of information and decision making is changing. Even in drug manufacturing, quality and increasing number of regulations coming in called for Indian pharma to continuously ensure enhancing its standards, transparency and accountability.

In the wake of the recent advancements on the regulatory landscape of the emerging markets, the experts noted that Indian pharma needs to be cognisant about the different regional drug guidelines implementation processes across  various global locations.

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