DoP forms expert committee to identify investment opportunities, bottlenecks in pharma industry

The Department of Pharmaceuticals (DoP) has created a six-member expert committee to suggest an action plan for maximum process improvements to attract investments in the pharma sector. The objective is to understand as well as identify bottlenecks that exist in the pharma industry. 

The six-member expert committee includes Dinesh Dua, Chairman, Pharmexcil; BR Sikri, President, FOPE; Mahesh Doshi, President, IDMA; VV Krishna Reddy, President, BDMA; Sudarshan Jain, Secretary-General, IPA and Dr Sumit Garg, Deputy Secretary, DoP.

The Committee will:

(i) Examine the number and type of approvals and compliances needed in the sector by investors for setting up operations and compare them with those of the best countries in the world.
(ii) Identify common hurdles and bottlenecks pertaining to the investments.
(iii) Based on the bottlenecks, prepare an action plan for maximum process improvements

To initiate the work, the first meeting of the expert committee took place on November 3 and several issues and challenges which are obstructing the growth of the pharmaceutical industry in India were discussed.

Dinesh Dua, Chairman, Pharmexcil, said, “Land and labour are the biggest bottlenecks, which is not only restricted to the pharma industry, but this issue is faced by other industries as well. Particularly in the pharma sector, there are some of the key issues, which need to be addressed on a priority.”

He said that the pharma industry in India is highly over-regulated and the industry seeks some relief in this context, particularly for units which are approved by the US FDA, EU, PMDA, KFDA, ANVISA, PICS, and COFEPERIS, to name a few. “India is a leader in the manufacturing of generic medicines, which are the most economical already cost-effective globally and still the industry is facing price control issue,” he said.

“Besides, tardy clinical trial procedures in India, particularly for new molecules approved in regulated markets, delays the introduction of new molecules. There is also a need to initiate an incentive programme for the industry-academia partnership for innovation in India,” he added.

BR Sikri, President, FOPE urged, “To accelerate growth and attract investments in the pharma industry there is a genuine need for a single-window concept which should be introduced. There is also a need for the deemed approval concept. It will expedite the disposal of applications in the real sense and therefore, the time frame has to be declared for each clearance.”

He mentioned, “Inter-ministerial group needs to meet frequently and the industry should also be involved in such discussions, so then they can also present their perspective. This will have a smooth adoption of adhering requirements. The government should give technical guidance to MSMEs along with financial support, which can be in the form of a nodal agency and one point reference for the industry. They should be capable of giving coherent suggestions so that people who need help can get proper support. Besides, gene therapy is another area which many States and the Central Government have not yet attempted, we should also be giving focus on this segment.”

Sikri also suggested, “There is a need to constitute a national level authority, for advance research in chemical drug development and biotech based products. Early-stage government R&D support needs to be provided to academia for pilot development of APIs for establishing viability. While we aim to become self-reliant we also need to protect indigenous products or to make anti-dumping laws industry-friendly.”

Mahesh Doshi, National President, IDMA highlighted, “There is no incentive to make in India.  Hence some multinational companies still manufacture their products in their countries and only market and sell their products in India.  The government must frame policies for all manufacturers to manufacture new, approved molecules in India.”

He informed, “We have also proposed to the authority that for Schedule M, there should be more guidelines and fewer rules. This will be based on best practices and can be continuously upgraded. 

He also spoke on OTC regulations and Sudarshan Jain, Secretary-General, IPA proposed that the topic should be discussed in detail and compiled report should be submitted to the DoP.

The authority has also directed the expert committee to submit a full report on the action plan for process improvements to attract investments in the pharma sector by November 6, 2020.