Apart from promoting pharmaceutical clusters, there are issues related to the API industry which need to be addressed in terms of environmental compliance, power and water costs, grant of compulsory licenses, central and state financial grants for CETPs. These were some of the thoughts deliberated as part of the 55th Indian Drug Manufacturers Association (IDMA) annual celebration under the theme ‘Indian Pharmaceuticals Nation’s Pride’ held in Mumbai recently.

Besides this, If adequate funding and training is provided for the Small and Medium Enterprises (SMEs), the number of WHO-GMP units in India can go up from the current 1,200 to 2,500. Therefore, SMEs need to be given adequate opportunities and need to be provided with purchase preference and price preference of about 15 per cent while participating in government tenders. There should be no turnover criteria for limiting the SMEs and WHO-GMP Certification which is meant for exports, said National President IDMA SV Veerramani on the sidelines of the event.

There are more than 7,000 SMEs in India and many of them have been started by Pharmacy Graduates. They represent the future of Indian Pharmaceutical Industry.

Whenever new regulations are introduced by the Government, the SMEs need to be given time and hand-holding for development, he added.

It was deliberated that many regulations will require training and funding for Technology Upgradation. Several Exporters can emerge from the SME segment. There is a steep increase in the cost of land, machinery and equipment and the project cost for the upgradation comes to around Rs.4 to Rs.5 crore. Technology upgradation scheme is being considered for medium sector, but should extend to Small Sector also.
There is also a need for ease of accessing funds / finance from banks – reduce paperwork, easy payment facilities, lower interests.

Technology upgradation funding for small & medium sector is the need of the hour and the Department of Pharmaceuticals (DoP) has been working on a very welcome initiative for Pharmaceutical Technology Upgradation Assistance for specific manufacturing units. The Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) envisages support to medium scale manufacturing units in bulk drugs and formulation manufacturing sectors for their upgradation from Schedule M compliance to WHO GMP compliance.

As discussed in IDMA submissions and interactions with DoP, the scheme needs to cover both formulation and bulk drug industry requirements. IDMA therefore urges that PTUAS should not be restricted to simply upgradation to WHO-GMP as aspiring industries are willing to upgrade their current WHO-GMP facility and also for advancement to EDQM, MHRA, US FDA and other regulated markets to boost exports.

Veerramani explained that IDMA had very fruitful interactions with Minister of State for Commerce and Industry Nirmala Sitharaman earlier in April and July 2016, in which Sudhanshu Pandey, Joint Secretary, Department of Commerce was also present. We were assured by the Government that various issues pertaining to environment, clusters, CETP, R&D, import substitution etc would be looked into in order to resolve them.

The Minister was also rightly concerned about how to overcome the dependence on China for imports of bulk drugs and intermediates and the unfair competition they posed. We informed the Commerce Minister that we are in agreement with the Drug Controller General of India (DCGI) proposal to hike the import fees as we are also being made to pay such fees when registering for exports to various countries. The API industry is struggling to survive not only because of the imports from China, but also due to internal pressures such as the NGT shutting down manufacturing units due to stringent environment issues. The year of APIs has gone by, but support from the Government for API sector is far from requirements.

Minister of State for Chemicals and Fertilisers Mansukh L Mandaviya, Sudhanshu Pandey, joint secretary, Department of Commerce, Chris Stirling, chairman, Global Life Sciences Practice, KPMG, Daara Patel, secretary-general, IDMA and joint health secretary KL Sharma were present on the occasion.

During the occasion, IDMA Margi Memorial Best Patent Award winners, the Corporate Citizen Award winners, Quality Excellence Awards and IDMA Research Paper Award winners were felicitated. National President S V Veerramani also welcomed Deepnath Roy Chowdhury as the next incoming national president of IDMA.

Source: pharmabiz