The development of drugs is an expensive exercise and that requires a lot of time | Photo credit: Brauns
China’s pharmaceutical industry is witnessing a seismic change as it goes from the production of generic drugs to prioritize innovative medicines, including small molecules, Chinese biological products and traditional medications. In comparison, India has not been able to take advantage of all its potential to help you be a truly innovative nation. For that, our defensive position on IP must change.
With a stronger regulatory regime and regulatory data protection (RDP), Chinese colleagues are significantly increasing their R&D spending, with companies such as Beigene and Hangrui that invest almost $ 1 billion annually. This has resulted in an outbreak in the number of patents presented, clinical trials carried out and an increase in the number of new Chinese medications approved by the USFDA. The lax regulatory requirements of India, on the other hand, have perpetuated the infraction of patents and combined with the deficiencies in RDP, discouraged our pharmaceutical companies to invest a comparative amount in innovation.
Complex exercise
The development of a new medicine is complex, expense, risky and that requires a lot of time, since regulators around the world require more safety and efficiency data. According to trips, members must provide a protection period door that the company’s test company or clinical trial is not used or directly or indirectly confident by another company to obtain marketing approval for the same medicine. This obligation is derived from the “considerable effort” necessary to demonstrate the safety, quality and effectiveness of an innovative medicine to the regulatory authorities, which require the presentation of said data as a condition to obtain marketing approval. This has been an outstanding obligation for India as January 1, 2000.
However, an escape in our drug regulatory mechanism places a new drug innovator in a considerable commercial disadvantage in a new posterior drug applicant.
For the approval of a new medicine approved in another country, an applicant must perform a local clinical trial in India to generate evidence that the new medicine developed and approved in the other country behaves similarly when used in the Indian population. However, there are provisions in the new rules of medicines and clinical trials 2019 under which local clinical trials can be renounced by certain medications.
However, regardless of their patent state, once a new drug is approved and introduced in the country, applicants are not obliged to perform clinical trials. During the first four years, subally new medicines applicants (small molecules) can carry out a limited study of bioequivalence and bioavailability. After that, a manufacturing license of a state license authority will be sufficient. This is greatly disadvantageous for innovative applicants and discouraged companies to spend time and money on R&D D.
To perform all its potential as innovative, India would need to provide RDP to small molecules. It will also encourage the development of new medications and the reuse of old medicines for unattered medical needs and for the endemic diseases of India.
As the understanding of genetics and molecular biology has expanded in recent decades, scientists can manufacture biological agents as therapeutic. If RDP protection extends to biological entities, the scope of innovation here is immense.
Fito-products and traditional medications are per se Not patentable. The exclusivity of the fixed period market will catalyze the growth of Ayurveda, Siddha and Unani (ASS) medications where it is important to establish, through clinical trials, the security and effectiveness of claims.
The Inter-Ministerial Advisory Committee, headed by Satwant Reddy, in its 2007 report, had recruited a five-year RDP for traditional medicines. He is an encouraging that RDP is being discussed in the context of the free trade agreements of India as well.
The writer is a managing partner of Corporate Law Group
Posted on April 24, 2025