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Indian pharma needs regulations of less prescriptive nature: Dr DBA Narayana
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Nandita Vijayasimha, Bengaluru
January 06 , 2025
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Indian pharmaceutical companies are operating in a highly regulated environment, with rules and compliance standards often being prescriptive. While these regulations are essential to ensure quality, safety and efficacy, they can sometimes lead to rigidity and stifle innovation, stated Dr DBA Narayana, chief scientific officer, Ayurvidye Trust and a regulatory expert.
Regulations that focus on outcomes rather than rigid processes allow companies to adopt innovative approaches to achieve compliance. Simplified regulations reduce the administrative burden and costs associated with compliance documentation and audits, he added.
There is a need to update the Drugs and Cosmetics Act and Rules where the progress is still eluding. Differences in views from the consumer and civil societies, together with scientific and technological advancements provide different perspectives making it difficult to find a common ground, he said.
Addressing the issue on whether regulations be ‘less prescriptive’ Dr Narayana said that the US being a more permissive society has taken an approach to state in the regulation on what is expected from the sector and does not provide regulations that are prescriptive. Regulations often state what is being regulated, permitted with or without restrictions, and what are totally prohibited. Prescriptive regulations appeal to most players but potentially suffers, if enforcement is weak, noted Dr Narayana.
Enforcement may be weak due to inadequate staff, untrained staff, dishonesty and manipulation in some parts of the enforcement chain with a time-consuming litigation process. It is high time for the industry and regulators to re-think alternatives to prescriptive regulations, he said.
We need to see guidelines, guidance notes, self-regulation, minimum regulation, and maximum management of the sector through training and surveillance. Here the United States Good Manufacturing Practices requirements for pharmaceutical industry is an example of the document stating what is expected from the manufacturer and marketer. The manufacturers pen down their own standard operating procedures which they believe help meet the GMP guidance and then submit the documentation on the SOPs (standard operating procedures), he noted.
There is lot of debate about reducing extent of regulation and promoting self-regulation by the pharma sector. But self-regulation is a double-edged sword and has also received criticism of non-compliance. Since regulations are legally enforceable and go through judicial processes in case of conflicts, the language used promotes more specificity and descriptiveness. Scientists feel that regulations should provide flexibility to the innovator, manufacturer, marketer, to operate in a way to meet the expectation. The code for ethical marketing practices falls somewhere between prescriptive regulations to guidelines promoting self-regulations, to deal with promotions, marketing, and medicines being prescribed by physicians, he said.
India is working on a new Drugs and Cosmetics regulation. It is suggested that this regulation needs careful analysis to decide what all should be regulated. This would also help in keeping balance between the Centre and the State in the areas of regulations and surveillance. The pharmaceutical sector should actively contribute to identifying and supporting in minimum regulations, maximum governance and participate in the training and surveillance. Too many regulations are bad and costly. However, it should be recognised that regulations should not only generate business but protect the consumer’s health, stated Dr Narayana.
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