Karnataka pharma industry sees that the constitution of a dedicated task force for the active pharmaceutical ingredient (API) sector is expected to boost the sector’s growth prospects. The move along with the China cancelling import duties on 28 medicines from May 1, are expected to spur revenue generation.

Currently India imports over 75 per cent of APIs from China and this led the government to address the import challenges besides pollution control clearances, set up API parks and initiate the production of many of these imported actives and chemicals from China.

According to Harish K Jain, Secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and Director, Embiotic Laboratories, the key objective of the task force is to reduce our dependency on imports for supply of APIs, key intermediates and speciality excipients.

India is home to a lot of bulk drug units and most of this work on N-1 and N-2 systems. Here whatever is the final product, these companies currently take one or two step prior to the last process of API manufacture to source the ingredient from China. These could be chemicals, intermediates and excipients. Therefore, we are either dependent on the whole bulk drug or in its intermediate from China, he added.

Now the panel formed to perk up the API sector should look at 20 top drugs consumed in the country where the volumes are quite high. A major effort is needed to manufacture big ticket products like Penicillin-G and Paracetamol so that the total dependency on critical drugs largely antibiotics will not be there on imports which are from China, stated Jain.

Earlier, India was recognised for its paracetamol production. It was manufactured from the benzene after which there were another 6 to 7 steps to arrive at the final product of this anti-pyretic. Today’s situation is that despite large domestic bulk drug companies, they are seen to import paraminophenol which is just one or two steps away from the final product Paracetamol. Now from benzene to Paracetamol there are eight steps for production. Indian pharma is only doing two steps for manufacture of this much dependent drug, he said.

Import dependency has escalated paracetamol prices in the last one-year from Rs.200 to Rs.325 per kg. Therefore the panel should look at ways to manufacture such APIs and save foreign exchange going by the current expertise and earlier production capability. So as a short-term, measures it should encourage the manufacture of high volume APIs which are antibiotics like penicillin-G, fluoroquinolones ciprofloxacin along with paracetamol, which could solve the import dependence issue, said Jain.

Another issue is that India has a long way to go as far as ease of doing business and environment clearance is concerned, said Jain.

Sharing a similar perspective on the expected positive outcome of the API task force, Anjan K Roy, founder and CMD, RL Fine Chem said that every move should be on a fast forward mode. The government has already delayed the required support given to the industry.

“The sector which is known for its qualified workforce, advanced infrastructure to manufacture much of these intermediates and APIs in the past is now importing. The irony is that it was the government move which led to stop manufacture here and look at imports because of indiscriminate pricing strategy. Now it is working to reverse the situation. Here the need is to ensure the government takes the industry support during its decision process,” added Roy.