Stymied by what they say is overzealous regulation, India’s’ drug companies are increasingly lobbying the government to reduce oversight of clinical trials, ease limits on new pharmaceutical ventures, and reduce regulations on new drugs.
Pharma firms in India are big business. Currently generating more than $36 billion in revenues, the sector is expected to grow that total more than six times by 2030. But the drug sector faces a number of hurdles. Along with the “unfavorable” domestic Indian regulatory environment, it lacks domestic access to sufficient raw materials. China is the source of more than 75% of the active pharmaceuticals used in India.
The pharma industry is also asking the government to better harmonize domestic regulations with those of the United States, Canada, and the European Union. Failure to tackle the regulatory issues, pharma firms argue, is undercutting Prime Minister Narendra Modi’s promise to bring down healthcare expenses and increase accessibility to all.