Karnataka Drugs & Pharmaceuticals Manufacturers Association (KDPMA) has made a representation to the Union government's department of chemicals and fertilizers to sort out issues of the pharma industry in the country.
Beginning with the adverse impact of active pharmaceutical ingredient (API) imports from China to the need for a common effluent treatment plant at every industrial area across the country and approvals for drug manufacture from State Pollution Control Boards to be based on bio-loads instead of item-based sanctions, the KDPMA has spelt out the hassles faced by the pharma units.
Chinese suppliers have made themselves comfortable in India only because of the Union government policies. India has the highest number of US FDA approved plants and this proves the country's capability in API production, but unhealthy competition from Chinese suppliers has resulted in adverse impact. Instead of being self dependent in the area of basic pharma raw materials and have an edge over China, India pharma sector is now over dependent on the products from the dragon land, Anjan K Roy, president, KDPMA and managing director RL Fine Chem told Pharmabiz.
The registration fee fixed by the Union government for each API from China is $2000 with a grant of registration within 15-20 days. But China is charging an exorbitant fee for Indian imports at $20,000 for each drug with an approval time frame of two to three years. This biased registration fee has affected the Indian API exports.
APIs and intermediates play a crucial role in the production of medicines. There is a need to maintain the highest quality standards in these raw materials. The department of chemicals must ensure that Indian pharma do not compromise on quality standards in the wake of high prices and short supply created by the Chinese suppliers, he added.
KDPMA also insisted on the need for a regulatory body to inspect the foreign API and intermediate supplier facilities particularly when Union government was encouraging imports from China. In this regard, India will need a panel of experts from the department of Pharmaceuticals and NIPER to inspect the foreign facility in coordination with the industry, pointed out Roy.
Another issue highlighted by KDPMA was that the Drug Price Control Order (DPCO) eroded the profits of companies in the wake of rising API and intermediates prices. The cost escalations in power and petroleum products have a direct impact on the production of the end-product. Under the present circumstances, it is not viable to adopt the DPCO guidelines.
The government should make it mandatory that every industrial area or zone should have a common effluent plant. For every new product, pharma units need to take a fresh approval from the technical advisory committee. Instead the State Pollution Control Board could certify and approve the bulk drug plant on the basis of hydraulic load standard.