Mumbai|New Delhi: The commerce ministry and the ministry of health are in extensive deliberations over the issue of inclusion of data exclusivity or protection provisions in the proposed drug regulatory and legal framework, senior industry officials told ET.
The matter has gained prominence in the last few weeks amid extensive lobbying by domestic drug industry groups, civil society, patient advocacy groups, and pharma multinationals. All the concerned parties made opposing claims to senior officials in the ministries on how data protection provisions could impact access to lifesaving drugs for Indian patients.
“An inter-departmental secretary level meeting was held recently but there was no consensus,” one of the officials said. “There is a positive indication on the acceptance of data protection in the regulatory provisions,” a second official added.
A third official termed it as an area of ongoing discussions, hinting a final decision has yet to be taken, and that the Centre may eventually explore a middle path, ensuring data protection for a specific term with certain caveats.
The issue of data protection hit the spotlight recently after commerce minister Piyush Goyal, highlighted that the India-EFTA Trade and Economic Partnership Agreement (TEPA) entails an investment commitment of $100 billion over 15 years and the creation of one million jobs. The four members of the European Free Trade Association (EFTA) are Switzerland, Iceland, Norway, and Liechtenstein. The investment commitment from the four-nation bloc, officials said, is partly predicated on India’s acceptance of data exclusivity or protection norms.
Data exclusivity ensures protection of drug tests and other data originating from the research of an invention of drug or therapy by an innovator or originator company.
While the matter pertains to the health ministry and the department of pharmaceuticals, the commerce ministry’s Department for Promotion of Industry and Internal Trade (DPIIT) is also looking at it as the request came from EFTA.
“The EFTA bloc has been requesting for a provision for regulatory data protection or the data which is generated as a result of clinical trials so as to encourage innovator companies and promote an innovative environment in India,” a commerce ministry official said. “Preliminary discussions are going on,” the official said, adding no proposals have been made by the Centre so far on the issue.
To secure marketing approval for a new drug, pharma firms must submit the data or clinical trial results to the local regulator for its review process. However, global drug makers contend that the same data developed over years of rigorous trials and forming the basis of approvals is used by subsequent filers or generic drug makers who skip such trials or bioequivalence studies, securing an easy path to gaining regulatory approvals.
This October, the Drug Controller General of India (DCGI) invited views on the “lack of level playing field”, as the government intended to review data protection laws.
According to a submission accessed by ET, the Organisation of Pharmaceutical Producers of India (OPPI), a lobby group comprising multinational pharma companies, has sought a provision of ten- year data protection for small molecules and 12 years for biological products. It stressed that this was in line with its European partners that grants ten-year data protection. “The government is considering a five-year data protection,” said a senior industry official.
However, Indian drug makers contend that data exclusivity is a layer of protection separate from patent rights. “Data exclusivity can block generic competition, delay competition, and price reduction, which would deprive patients of medicines at affordable prices,” an official said.
“A 1-3 year or 3-5 year data exclusivity period after an originator medicine is licensed is being considered,” the person said. “Certain American companies have proposed a 10-12 year data protection period and the protection to start from the date when they apply for in India, not globally. European majors have sought around a 6-8 year exclusivity period”.
The Working Group on Access to Medicines and Treatments, a patient advocacy group, underlined that having data exclusivity in India would have delayed by several years the launch of affordable versions of Swiss drugmaker Roche’s Risdiplam, used for treating spinal muscular atrophy (SMA), denying countless SMA patients access to a lifesaving treatment. “Data exclusivity will not be just a technical tweak; it will be a direct threat to the survival of many people,” the group cited a patient as saying.
India’s Natco Pharma launched generic versions of Risdiplam at ₹15,900 per bottle, fraction of Roche’s price of ₹6 lakh, following a favourable court verdict recently.
