04 Jun 2012, Rahul Koul, BioSpectrum
India recently decided to revive three of its public sector vaccine manufacturing units and a strong argument in support of their revival is that they will act as a buffer in times of medical emergencies. The supplies from government units can be faster than private players, claim those who support the revival.
So, did the shortage of vaccines supply from the private sector prompt the government to revive the vaccine units? Industry experts deny it. The industry, while welcoming the government move to revive the units, says there is unnecessary mistrust about private players in the market.
Mr KV Balasubramaniam, MD, Indian Immunologicals (IIL), Hyderabad, says, "Shortage of vaccines is a thing of the past. That happened some years ago when the department units were suddenly closed down due to GMP issues. They were not given time to modernize and improve."
He says the entry of private players bridged a substantial part of that gap. "This is a fact that has not been adequately acknowledged. We now meet a bulk of the requirements of DPT, TT and Hep B vaccines for the Universal Immunization Programme. We had to discontinue measles vaccine due to issues with the way the vaccine was getting mixed up with diluents causing serious adverse events. The situation would have been worse if IIL had not stepped in," he says.
Dr Krishna Ella, president, Vaccine Manufacturers Association of India, agrees with him. "The apparent shortage of vaccines, if any, from the private manufacturers was due to the lack of advance planning by the government to procure vaccines from them. Indian vaccine manufacturers also supply vaccines to other countries, the United Nations Children's Fund and Global Alliance for Vaccines and Immunization," he points out. Vaccine Manufacturers Association of India represents top vaccine manufacturers of the country, such as Bharat Biotech, Biological E, Panacea Biotec, Serum Institute of India and Shantha Biotechnics.
Many say that there is also a misconception about the price of vaccines. According to the industry, prices went up not because of shortage of vaccines, but due to demand for higher levels of quality compliance and need to incorporate vaccine vial monitors (VVMs). VVMs are said to be the single biggest cost component as they are sourced from a WHO-approved supplier outside India who has a monopoly on this area. The other argument is that manufacturers have to also account for inflation and a depreciating rupee.
"There is now sufficient capacity in the country to meet the demand for vaccines under the UIP and you are not going to hear of shortages. There are a sufficient number of manufacturers for almost all the UIP vaccines, except the measles vaccine where there is just one manufacturer. Not withstanding this, there is definitely a case for reopening the units with good GMP in place to provide vaccine supply security," says Mr Balasubramaniam.