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Recently, Intas Pharmaceuticals and Biological E had reached out to the National Pharmaceutical Pricing Authority (NPPA), asking for exemption for their products under para 32 of the Drugs Prices Control Order (DPCO), 2013, which gives powers to the NPPA to exempt certain class of drugs from price control for a period of five years. Under the provision, the price cap doesn’t apply if a new drug is developed through a unique and indigenous process, is patented under the Indian Patents Act and is not produced elsewhere.
However, the NPPA has asked the patent office to participate in the meetings to discuss the issue. “An officer not below the rank of deputy controller of patents, design and trade marks from the office of controller general of patents, design and trade marks (CGPDTM) who is well versed with the subject matter would be invited for deliberations. It was also decided that the agenda for the deliberations on the applications received under para 32 of DPCO, 2013 may be sent in advance to CGPDTM,” said the NPPA, according to the minutes of the meeting, a copy of which was seen by ET.
Intas had sought exemption from price control for its antipsychotic formulation, Clozapine extended release capsules, stating that the provisions of DPCO, 2013 are not applicable since the new drug is being produced in the country by a new process through indigenous research and development and is patented under the Indian Patent Act, 1970.
Similarly, Hyderabad-based Biological E had sought exemption for its pneumococcal polysaccharide conjugate vaccine.
The exemptions, if granted, will be valid for five years. The provisions of para 32 of DPCO, 2013 also stipulate that the exemption would be applicable only when the companies produce requisite documents before the government. The decision to allow exemption to the new drugs for five years had also triggered controversy earlier, as to whether it could be a self-invocatory provision or should be provided by the NPPA after due consideration.
