Updated on 16 April 2012
At Panacea Biotec, vaccines account for about 70 percent of revenues. It has ultra-modern production facilities complying with international standards and cGMP. Similarly, Bharat Biotech International too has been observing the highest quality standards at its manufacturing units. "We are aware that our products are administered to children and adults worldwide. We have to maintain the highest standards of quality. Absolutely no compromise will be tolerated at Bharat Biotech for quality," says Dr Krishna M Ella, CMD, Bharat Biotech.
The biopharmaceutical manufacturing facility at Reliance Life Sciences in Mumbai is already approved by the European Medicines Agency (EMA).
Mr KV Subramaniam, president, Reliance Life sciences, says, "The manufacturing facilities at Reliance Life Sciences are built as per US Food and Drug Administration (FDA) and EMA standards."
Talking about his company, Dr Cyrus Karkaria, president, biotechnology, Lupin, "Lupin adheres to quality demanded by developed markets because at the end-of-the-day that is where we want to be and we are striving to get there as soon as possible. The opening up of the US biosimilar pathway would lead to a world of opportunities for companies, such as Lupin, in India."
Setback in quality
In the recent past, there have been instances where some of the major companies dealing in biologics have suffered setbacks in quality adherence. In April 2010, the WHO ordered recall of Shantha Biotechnics's pentavalent vaccine, Shan5, from the market after finding some white sediments in the vials of certain samples. The recall was ordered as a precautionary measure. Shan5 is a DTwP-hepatitis B-Hib vaccine.
Speaking about the current status of Shan5, Dr Harish Iyer, CEO, Shantha Biotechnics, says, "Getting the pre-qualification approval from the WHO for Shan5 is a high priority for us. We are working hard towards making necessary changes, so that we can again start supplying it by 2014 to the agencies. We hope to start bidding for tenders for the pentavalent vaccine in the next round."