Even though there are competent companies in India like Wockhardt, Biocon, and Shantha Biotech manufacturing quality recombinant products like Erythropoietin and G-CSF, exports of recombinant products are negligible. The main reason for such poor performance is stringent regulatory procedures required overseas for every recombinant product, according to Dr. Dhananjay Patankar, head, Biotech Division, Indus Biotherapeutics.
Regulatory pathways for biological products have not been framed as yet in US and Europe. As a result, an exporter has to meet the available regulatory standards on a country-to-country basis. Every product has to be tested right from animal studies to post marketing surveillance, which is highly difficult, he added.
“Recombinant products are genetically modified ones. As genes vary from one place to another so also genetic products, creating a variation in efficacy of the assimilated proteins across regions. Stringent step-by-step procedures along with documentation have to be undertaken during the manufacture of a recombinant protein. The results have to match on a consistent basis, which is difficult. Even if the product is approved in US, the exporter has to retry the product right from the scratch till the efficacy is proved, for an approval in UK,” said Dr. Patankar.
An IIT alumni, Dr. Patankar was speaking at the symposium organised by the Chemical Engineers Association (Chea) and IIT Bombay titled “Biotechnology: A New Dimension To Chemical Engineering” at IIT B on March 13, 2004.
The other speakers in the symposium included Satish Velankar, director, business development, Lupin Ltd and Dr. Prabuddha Ganguli, advisor, Vision-IPR, Dr. H. K. Varma, Scientist-in-charge, Biomedical Division, SCTIMST, Dr. Surekha Zingde, deputy director, ACTREC and Dr. Jayant Udgaonkar, Dean, Faculty, NCBS.
Dr. Ganguli stressed upon the need to respect other’s intellectual property and the importance of filing patents. Dr. Ganguli is a professor of IPR at IIT Bombay.