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India's Drug Approval Rules Spark Debate Over Uneven Application

Experts are raising concerns over potential inconsistencies in how India's New Drugs and Clinical Trials Rules of 2019 are being applied in practice. The rules allow clinical trial waivers based on a drug's prior approval in specific foreign markets, but this principle may not be applied uniformly to all applicants. A major issue is the lack of regulatory protection or data exclusivity for indigenously developed new drugs not yet approved in major regulated markets. This perceived inconsistency could disincentivize original research by Indian pharmaceutical firms, particularly MSMEs, at a time when the country aims to become a global innovation hub.

Key Points: India's New Drug Approval Rules: Inconsistent Application?

  • Clinical trial waiver criteria under NDCT Rules, 2019
  • Gap between written rules and practical application
  • Concern over lack of data exclusivity for Indian innovators
  • Potential inconsistency favoring imitation over original research
3 min read

Regulatory Grey Zone Sparks Controversy: Are India's New Drug Approval Rules Being Applied Unevenly?

Experts question uneven application of India's 2019 drug trial rules, highlighting gaps in waiver criteria and data protection for indigenous innovators.

"predictable and balanced regulatory interpretation plays an important role in encouraging research-led innovation - Industry Stakeholders"

By Nikkhil K Masurkar, New Delhi, April 9

Questions are being raised over how India's new drug approval framework is being interpreted, with experts pointing to a possible gap between the written provisions of the New Drugs and Clinical Trials Rules, 2019 and their application in practice.

Under the NDCT Rules, clinical trials in India may be waived only under specific conditions, primarily when a drug has already been approved and widely used in certain foreign jurisdictions, supported by adequate safety data and scientific justification. Importantly, these provisions are linked to the characteristics of the drug itself, rather than the identity or sequence of applicants.

However, despite references to "subsequent applicants" in regulatory discussions, there is no clearly defined statutory pathway that allows later applicants to rely solely on data generated by an earlier applicant where the drug does not meet waiver criteria under Rule 101.

Experts suggest this creates a potential inconsistency. If a drug qualifies for a waiver based on global safety and prior approval in specified countries, the same principle should logically apply to all applicants. Conversely, if a drug does not meet these criteria, then similar evidentiary standards may need to be applied consistently across applicants.

An additional concern relates to new drugs developed indigenously in India that are not approved in regulated markets such as the US, UK, EU, or Japan. In such cases, the Indian innovator undertakes the full cost and risk of development, including research and regulatory submissions. However, these products may not receive any form of clinical data exclusivity or regulatory protection, even when they represent first-in-class innovations originating in India.

Industry observers note that in certain instances, subsequent approvals for similar products have reportedly been granted within a relatively short period of the innovator's approval, even though the drug was not approved in any country specified under Rule 101. This has raised questions about consistency in the interpretation of the NDCT framework, particularly in the context of indigenously developed medicines.

Stakeholders highlight that predictable and balanced regulatory interpretation plays an important role in encouraging research-led innovation, particularly among Indian pharmaceutical MSMEs. Without sufficient clarity, there is concern that the incentive structure may unintentionally favour imitation over original research.

As India aims to strengthen its position as a global hub for pharmaceutical innovation, legal clarity and consistency in regulatory decision-making may be important both for industry confidence and for maintaining public trust in the safety and effectiveness of new medicines. (Disclaimer: The author is CEO- ENTOD Pharmaceuticals. Views shared here are personal).

- ANI

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Reader Comments

P
Priyanka N
As someone working in clinical research, I see this grey area daily. The intent of the 2019 rules was good, but implementation is patchy. Consistency is key for patient safety AND for a fair market. 🧪
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Rahul R
If a later applicant can get approval quickly without doing their own trials, it undermines the first company that took all the risk. This is not just about rules, it's about ethics and encouraging real innovation.
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Sarah B
While the article raises valid concerns about consistency, we must also ensure that any exclusivity doesn't keep drug prices high for the common man. India's balance between innovation and affordability is unique and must be preserved.
K
Karthik V
The CDSCO needs to issue clear guidelines. This "jugaad" in regulation helps no one in the long run. It creates uncertainty and might push our best researchers to look outside India for developing their drugs. Very worrying trend.
M
Meera T
Finally, someone is talking about this! My husband's company is a small pharma MSME. They developed a novel formulation but are now scared a bigger player will copy it in months using this loophole. Where is the incentive? 😔

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