Planning Commission has suggested tax deduction for the pharmaceutical companies to cover activities such as international patenting costs, regulatory consultants, outsourced research and development services and patent litigation expenses.

According to the Plan document recently approved for the 12th Five Year Plan, the panel has called for reviewing the regulatory system to allow the tax deduction for these services, which are currently not covered, but demanded by the pharma industry for long.

The recommendations by the Commission also include capacity building of private sector to meet WHO - GMP standards and other international manufacturing standards, enabling the Indian pharmaceutical industry to develop competence in advanced areas of drug manufacturing like dedicated research facility in bulk drugs, improving processes of manufacturing generics and new APIs, among other things.

“Develop common infrastructure in drug discovery and development, such as, manufacturing, distribution, exports, medical devices and so on; appropriate coordination between relevant ministries/departments and stakeholders to build a coordinated strategy to tackle non-tariff barriers through counter measures and during signing of FTAs; develop competencies for 2D Bar-coding for SMEs; developing capacity of Central Drug Standards and Control Organisation (CDSCO) to ensure timely clearance for new drug trials, pharmacovigilance, and assistance to the willing industry members to shore up their technical capacities for better regulatory compliances and adequate number of labour inspectors,” are also among the recommendations.

The Planning Commission also called for developing, evolving and rationalising regulatory frameworks for biosimilar drugs, fixed-drug combinations, clinical trials and early drug development. Another recommendation is development of an ecosystem to take advantage of the opportunity in clinical research and development of Clinical Research Centres for high-risk trials such as phase-I.

The panel also wanted the Government to create a level-playing field for domestic manufacturers in the bulk drugs industry and provide incentives for new drug development.