Magazine Article | July 31, 2013

Can India Achieve cGMP For Vaccines? Does It Matter?

Source: Life Science Leader

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

In May, amid much fanfare, the Indian government announced the development of a new low-cost vaccine proven effective against the diarrhea-causing rotavirus — one of the leading causes of death across the developing world. According to reports, the Phase 3 clinical trial results of Rotovac, being developed by India-based Bharat Biotech, indicated it was safe and effective in the 6,799 infants who were injected with the vaccine. This news came just one week after GlaxoSmithKline (GSK) and Merck agreed to offer a 95 percent discount off the purchase price for their respective HPV vaccines (Cervarix and Gardasil) to the Global Alliance for Vaccines and Immunizations (GAVI Alliance), which delivers immunizations to the developing world. Interestingly, both GSK and Merck also make rotavirus vaccines (Rotarix and RotaTeq), which the GAVI Alliance is able to acquire for $2.50 a dose. If approved, Bharat Biotech has pledged to sell Rotovac for $1 a dose. Here are the problems I have with this news.

First, in December 2011, WHO suspended Bharat Biotech from being able to supply the hepatitis B vaccine (Revac-B+) as a result of a failed site audit of the company’s Hyderabad, India, facility during a prequalification evaluation for possibly manufacturing two different vaccine types. Apparently the audit found deficiencies in the implementation of cGMP, as well as in the company’s quality management systems. The company’s website claims to have manufacturing, quality, and control procedures conforming to stringent standards set by national and international authorities, including the USFDA, and to be the first biopharma facility in India to be audited and approved by the Korean Food & Drugs Administration (KFDA). The company claims to have been audited by a number of other regulatory authorities but doesn’t list the two most respected in the world, the European Medicines Agency (EMA) and the USFDA. So perhaps Bharat can make it cheaper, but can it make it safer?

The second problem I have with this news revolves around a statement by India’s secretary of the Department of Biotechnology, Dr. K. Vijay Raghavan, quoted as saying, “The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.” I fully expect the Indian government will approve the license as it has shown favoritism towards Indian manufacturers for years under the guise of bringing cheaper drugs to the Indian people (e.g. see the Supreme Court of India denying Novartis patent protection for Gleevec). But it’s that statement, “saving thousands of lives,” that really bothers me.

That’s because, no matter if the vaccine is approved and offered at $1.00 a dose, it’s how the medicine is administered that really matters. A study by the International Clinical Epidemiology Network (INCLEN), an international network of healthcare professionals, found 62 percent of the injections administered in India to be unsafe. It is estimated that more than three billion injections are administered annually in India, meaning 1.89 billion are unsafe — primarily the result of healthcare providers reusing needles and syringes intended to be single use. But whether it be hepatitis, the rotovirus, cervical cancer, or some other type of serious ailment, it seems to me that India should focus as much effort on safely administering drugs as it is on making drugs for less money.