India’s biotechnology companies demonstrated their manufacturing prowess for a variety of products urgently needed for the country and many parts of the world during the Covid years. Impressed by the country’s capabilities, orders are pouring in from many parts of the world to manufacture a host of biological products to ABLE’s member companies.

Our companies are not in a position to quickly respond to these orders due to some obstacles in the current regulatory processed related to export of such products from the country. Our companies possess the capability to manufacture for purely export even some of the biological products that are new and not currently approved for use in the country or in the process of seeking regulatory approval.

In recent interactions with officials of Commerce and other ministries that are pushing to achieve the Prime Minister’s vision of India achieving $100 billion from only biological manufacturing services, ABLE has been requesting for a quick change in the current process. ABLE has requested government agencies to issue a one-time No Objection Certificate (NOC) /manufacturing license followed by Certificate for Pharmaceutical Product (COPP) for pharmaceutical and biological products that fall under unapproved/banned drugs/new drugs cattery solely for “export purpose” instead of current “country specific and quantity specific” approvals.

Our member companies say that such one-time manufacturing license will shorten the exports process from the current 8 to 10 months to just 2 months and will provide a big boost to India’s BioEconomy and establish our country as a reliable, efficient exporter of biological drugs. Most of these export enquiries are for products approved in other countries and will be a great economic opportunity to showcase our capabilities to the world.

I am also happy to announce that ABLE has a taken a new initiative to help the industry’s constant demand to have young employees ready to be recruited and deployed in their companies without having to spend too much time to get them ready for the jobs. Kewaunee Labway India, Patron Gold Member and Aragen Life Sciences together in partnership with CSIR- Indian Institute of Chemical Technology (CSIR-IICT) and ABLE have launched a Biotech Finishing School Program on July 4th at IICT that aims to provide hands-on practical training to postgraduate students in analytical chemistry and make them job ready especially in CRO/CDMO companies.

ABLE is supporting the program and had reached out to its network of academic institutes and faculty on their behalf. We have got a very good response and the screening of candidates who have applied is underway. The first batch of 20-25 candidates will be starting their training from the first week of August 2023. There will be many more batches of this excellent training program and I request all the biotech educational institutions to share the information about this initiative with their students so that they can benefit from it.

G S Krishnan

Hon. President, ABLE