Modern and Patient Centric new D n C Act and Rules: Need of the Hour

The central government needs to legislate a strict law to provide better health and medical facilities to one and all. 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 of PSM India.

“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 the pharma industry. Therefore, we are insisting that the government should redefine the rules to bring in absolute clarity,” said Misra.

Recently, in a communication to the Union Health Minister JP Nadda, Misra specified that to achieve the promises of the Universal Health Coverage (UHC), we need to implement new laws relevant to the present scenario, which is without compromising on safety and quality of healthcare facilities for every citizen. “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 access to health care like online pharmacies and tele-medicine with robust trace and track mechanism in place,” stated Misra.

The Bureau of Research for Industry & Economic Fundamentals study revealed that the monthly expenditure incurred over medicine is up to Rs. 5000 by most of the respondent consumers. Moreover, the survey also revealed that there is a huge price variation among the different pharmacies for the same medicine. There are instances wherein the consumers were offered with an alternate or generic brand for the same composition during purchase. It was also reported that consumers found generic brands to be cheaper in price.

The absence of qualified pharmacists to dispense medicines at pharmacies emerged as a major issue. Thus, consumers did not receive proper counselling on the administration of medicines at their preferred medical stores. “This is where a modern law is required to be drafted to suit the changing business environment,” said Misra.

“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.”