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Nandita Vijay, Bengaluru June 13 , 2019
Even as the Union health ministry is advocating a ‘generics-only’ model to make healthcare affordable and accessible to the common people of the country, healthcare experts question whether the country is ready for such a change.

In this scenario, it is necessary for the newly formed government to focus on making good quality generic drugs available in the market since the poor quality drugs will only deteriorate the growth of the pharmaceutical industry and hamper India’s position in the global market, said the experts.

The Bihar health department on June 1, 2019 had issued a directive to the doctors of the state government-run hospitals, to prescribe generic medicines and essential drugs list available at hospital outlets. The letter stated that this directive is to be enforced from June 2 onwards.

The move by the Bihar government follows a directive from the Medical Council of India (MCI) in 2017 which mandates every physician should prescribe generic names and ensure rational prescription of drugs. Subsequently, in April 2017 Prime minister Narendra Modi had also announced plans of putting a legal framework to ensure doctors prescribe generic medicines. This move by the government is aimed at reducing healthcare expenses, but it should not be at the cost of quality, experts warn.

Dr. Neelam Mohan, director - paediatric gastroenterology & hepatology, Institute of Digestive and Hepatobiliary Sciences, Medanta said that when generics are prescribed medical fraternity prefers the ones manufactured by a company which follows Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations.

The government’s decision to ask doctors to prescribe a generic name has made things complicated. I don’t know where it was manufactured and whether good manufacturing regulations were strictly followed. We need a lot more clarity about manufacturing guidelines, said Dr Mohan.

“Branded generics manufactured by research-based companies are backed by high-quality standards, reliable and sophisticated supply chain infrastructure, and clinical science and innovation. Everyone deserves to be benefited by the value branded generics bring in the form of assured quality standards, proven safety and efficacy, better absorption, and reduced side-effects. Generating awareness around the value of branded generics and differences between branded and unbranded versions is the key to aid patients in taking informed decisions and refuse trust in the overall Indian healthcare system,” said Amir Ullah Khan, Economist and Director of Research, Aequitas.

The absence of an international standard drug regulatory mechanism deters Indian doctors from trusting most generic drugs. The doctor prescribes a drug keeping in mind the level of efficacy assured, he said.

“When it comes to healthcare, it is not a battle between expensive brands and cheaper generics, but a movement for quality and safety of medication for consumers without compromising on the expected outcomes and the Standard Treatment Guidelines. Even as health policy circles frequently blame branded drugs for raising healthcare costs, the argument lacks substance. In fact, branded generics were introduced as a premise to make simple and complex drugs available at affordable prices,” said Bejon Kumar Misra, founder of Patient Safety and Access Initiative of India Foundation.

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