Patient Centric new D&C Act and Rules soon!

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Union government should work to bring in a new, modern, comprehensive and patient-centric law on par with global regulations to regulate the drugs and cosmetics sector, said Bejon Misra, founder director, Patient Safety and Access Initiative of India Foundation (PSAIIF).

The government needs to legislate stringent laws to protect the health and safety of the people. “We need to abandon the current archaic D&C Act 1940 & Rules 1945 and move away from the inspector-raj era. The pharma industry in its present form and capability is looking for clarity with no legal complications. “There should be absolutely no ambiguity in the definition chapter which needs to be more lucid to avoid litigations. For instance, in the case of the 344 fixed dose combinations (FDCs) banned by the government, even the judiciary is confused due to a lack of coordination between the central and state drug regulators. This is hampering the growth of pharma industry. Therefore, we are insisting that the government should redefine the rules to bring in absolute clarity,” Misra told Pharmabiz in a telecon.

In a communication to the Union health minister JP Nadda, Misra stated that in order to fulfill the expectations of the Universal Health Coverage (UHC), without compromising on safety and quality of healthcare for poor and senior citizens, the need of the hour is to enforce norms relevant to the current context.

“We have now come together to partner and fight against the menace of spurious drugs and not-of-standard quality medicines found in the supply chain which is primarily attributed to the lack of accountability and transparency in the manufacturing and distribution system. There is a need to provide multiple choices to the citizens to improve accessibility to healthcare like online pharmacies and telemedicine with robust trace and track mechanism in place,” stated Misra.

As per the Bureau of Research on Industry & Economic Fundamentals study, the monthly expenditure incurred for medicine purchase is around Rs.5,000. The respondents of the survey also revealed that at times they were charged different prices for the same medicine at different pharmacies. Unavailability of qualified pharmacists to dispense medicines at pharmacies emerged as a major issue. Consumers did not receive proper counselling on the administration of medicines at their preferred medical stores. Majority of the respondents also recalled instances wherein they were offered with an alternate or substitute brand for the same composition during purchase. It was also reported that consumers found the alternate brands to be cheaper in price. “This is where a modern law is required to be drafted to suit the changing business environment,” he said.

There is also a need for well-defined rules in sync with international regulations mandating provisions of electronic submissions to remain up-to-date with latest global business practices, said Misra.

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