MNC pharma lobby pushes for single drug authority here
HYDERABAD: Alobby group of multinational pharmaceutical companies (MNCs) is pushing for replacing statebased multiple drug authorities with a single body for more effective protection of intellectual property (IP) and patents.
The Organisation of Pharmaceutical Producers of India (OPPI), which represents 22 pharma companies, including Abbott, Pfizer, Novartis, Novo Nordisk and Sanofi, also wants specialised patent courts for fast disposal of patents and IP disputes.
Kanchana TK, director general, OPPI, said the government’s move to dismantle Foreign Investment Promotion Board (FIPB) and automatic foreign direct investment (FDI) approvals doesn’t serve the intended purpose unless drug research and development (R&D), innovation and exports are adequately incentivised. “What is worrying global pharma companies in India is the IP protection and unpredictability over ease of doing business,” Kanchana told ET. “The budget did not address our key appeals for a simplified regulatory regime without multiplicity, a stable price control mechanism in consultation with the industry, and a simplified clinical trials regime.”
OPPI insists that the government should immediately look at fast-tracking policies that impact human lives. “Decisions on new therapies and new drug approvals should be fast-tracked by circumventing the usual regulatory process while ensuring safety measures in the form of number of clinical trials and data,” she said.
Kanchana said OPPI wants the government to also look at revamping its teams of technical experts in the drug approval machinery, given the emerging technologies and revolutionary drug therapies.
Insisting that India should do away with the multiplicity of state-based drug regulators in the interest of both patients and global drug innovators, Kanchana said, “State-based drug regulators are not equipped to check before granting manufacturing approvals if the drug was patented by someone else, leading to patent infringement. Secondly, state drug regulators are also not equipped to check if the new drug they are approving for manufacturing has all the requirements in place in terms of patient safety like clinical trials”.
Flagging concerns over ill-equipped state drug regulatory bodies, Kanchana said, “We are worried that the states are not equipped with data, which leads to infringing on patients’ safety and then on patents.”
According to Kanchana, pharma companies are disappointed with the government’s proposals in the Budget. OPPI is of the view that most of the initiatives will become redundant unless serious measures are taken to protect innovations and patents in India, including setting up of some kind of a universal drug authority that monitors drug manufacturing approvals across the states.
The Organisation of Pharmaceutical Producers of India (OPPI), which represents 22 pharma companies, including Abbott, Pfizer, Novartis, Novo Nordisk and Sanofi, also wants specialised patent courts for fast disposal of patents and IP disputes.
Kanchana TK, director general, OPPI, said the government’s move to dismantle Foreign Investment Promotion Board (FIPB) and automatic foreign direct investment (FDI) approvals doesn’t serve the intended purpose unless drug research and development (R&D), innovation and exports are adequately incentivised. “What is worrying global pharma companies in India is the IP protection and unpredictability over ease of doing business,” Kanchana told ET. “The budget did not address our key appeals for a simplified regulatory regime without multiplicity, a stable price control mechanism in consultation with the industry, and a simplified clinical trials regime.”
OPPI insists that the government should immediately look at fast-tracking policies that impact human lives. “Decisions on new therapies and new drug approvals should be fast-tracked by circumventing the usual regulatory process while ensuring safety measures in the form of number of clinical trials and data,” she said.
Kanchana said OPPI wants the government to also look at revamping its teams of technical experts in the drug approval machinery, given the emerging technologies and revolutionary drug therapies.
Insisting that India should do away with the multiplicity of state-based drug regulators in the interest of both patients and global drug innovators, Kanchana said, “State-based drug regulators are not equipped to check before granting manufacturing approvals if the drug was patented by someone else, leading to patent infringement. Secondly, state drug regulators are also not equipped to check if the new drug they are approving for manufacturing has all the requirements in place in terms of patient safety like clinical trials”.
Flagging concerns over ill-equipped state drug regulatory bodies, Kanchana said, “We are worried that the states are not equipped with data, which leads to infringing on patients’ safety and then on patents.”
According to Kanchana, pharma companies are disappointed with the government’s proposals in the Budget. OPPI is of the view that most of the initiatives will become redundant unless serious measures are taken to protect innovations and patents in India, including setting up of some kind of a universal drug authority that monitors drug manufacturing approvals across the states.
