India’s pharmaceutical sector faces challenges amidst weak IP regime

Applicants seeking market approval encounter uncoordinated processes amongst federal and state agencies.

India’s pharmaceutical industry is projected to hit $42.9b by 2028 with a compound annual growth rate of 6.3% in local currency terms. However, a weak IP regime poses a challenge to the sector's potential expansion.

A BMI report said that Section 3(d) of the Patent Act undermines incentives for biopharmaceutical innovation, as it restricts patentability for improvements unrelated to efficacy.

Another major challenge for biopharmaceutical applicants seeking market approval is the opaque and uncoordinated process among federal and state agencies.

“Four years after a medicine's initial approval in India, simply obtaining a license from any state drug regulator is sufficient to manufacture and market the product, causing harm to innovators, and subsequent producers,” the report said.

Moreover, The 2024 Special 301 Report issued by the U.S. Trade Representative highlighted the country’s burdensome formalities for IP filing and significant delays in processing.

“An unpredictable IP regime may deter innovators from entering the market at the pace required by the National Biotech Strategy,” BMI added.