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[email protected]: Drug Makers Seek Freedom From Dependence On Chinese Imports And Unforeseen Regulatory Changes

No lapses can be greater than the loop holes in the country’s medicine making and distribution market

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No lapses can be greater than the loop holes in the country’s medicine making and distribution market.
Gorakhpur tragedy, which led to the death of several helpless infants, has reminded us that mending gaps in country’s healthcare system could literally nip the precious lives in the bud.
Indian pharmaceuticals and healthcare industry on the eve of Independence Day seeks freedom from the variety of ailments. “Getting freedom from the dependence on Chinese imports is the priority,” said R.C Juneja, CEO of Mankind Pharma. India imports over 85% of active pharmaceuticals ingredient (APIs) from China. “We also need freedom from the ambiguity on regulations to monitor sales of drugs online, guidelines on electronic health records and laws to deal with clinical trials.”
Moreover, drug makers are trying to seek freedom from the traditional business model which is based on exporting vanilla generics across the globe. “The need of an hour is to invest more into research and development of complex generics,” said Sujay Shetty, partner and leader, pharmaceuticals and fife Sciences at PwC India.
“Getting the boost in investments along with several other incentives such as tax breaks is important. It is the high time to ask for a relief from the unease of doing business in India,” Shetty added.

Experts further added that government should relax industry from the anxiety of unnecessary price controls and regulations. “Pricing policies without adequate consultations with the industry are not good and drug makers need freedom from the uncertainties. We also need freedom from the outdated curriculum for technical staff,” advised Sunil Attavar, president, Karnataka Drugs & Pharmaceutical Association (KDPA). Also, the industry needs to do away the culture of applying shortcuts.  “We need to change our ‘chalta hai” attitude. An attitude to apply shortcuts, specially manufacturing processes, will help us to reduce the complaints raised by global health regulators,” Attavar said.

Pharma sector is also anxiously waiting for the clarifications in patent and legal regime. “There are laws which requires simplification and quick approval process. Also quality of manufacturing needs to be enforced based on good standards,” said Hitesh Sharma, national leader for life sciences at a consulting firm, EY.

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