New Delhi: A Supreme Court notice to the Centre on 20 February and a critical report submitted in Parliament two days earlier may force the government to review a decision to suspend production at three state-owned units that made vaccines against tetanus, tuberculosis, measles and other infections.
The halt in production at the three units in January 2008 has affected the supply of primary vaccines for the government’s universal immunization programme (UIP), raised concerns about potential vaccine shortages and led private sector vaccine producers to push up prices.
“There is a lot of pressure from Parliament and the Prime Minister’s Office on the government to source these essential vaccines from its own units,” said a ministry of health and family welfare official who didn’t want to be named. “So, the government is now rethinking its decision...”
Drop of life: A child gets polio vaccination during a global polio eradication campaign in Moradabad, Uttar Pradesh. Sanjit Das / Bloomberg
The Union government has suspended production at the Central Research Institute (CRI), Kasauli, Pasteur Institute of India (PII), Coonoor, and BCG Vaccines Lab (BCGVL), Chennai, since 15 January 2008 because of their failure to comply with the good manufacturing practices (GMP) clause under the Drugs and Cosmetics Rules, 1945, as well as those prescribed by the World Health Organization, or WHO.
The GMP is a set of quality control guidelines. The government also cited defects in the condition of the buildings, which were decades old, and their infrastructure in ordering the units to shut production.
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The government had planned to upgrade the plants and use them to produce vaccines against influenza and yellow fever and serums against snake venom, among others—none of which comes under the UIP.
After production at the three units was stopped, private sector pharma companies that had earlier promised to supply the government essential vaccines at very competitive prices had in some cases substantially raised prices, said the ministry official.
The government is now procuring these vaccines through open tenders from the private sector.
“But this will not continue,” said the official, adding that the Centre had not been entirely able to meet states’ demand for vaccines under the UIP.
According to experts as well as the 18 February report by the parliamentary standing committee on health and family welfare, headed by Amar Singh of the Samajwadi Party, the closure of the units has led to a shortage of essential vaccines.
“The closure of production at three of the most important vaccine PSUs (public sector units) under the Union health ministry in January 2008 using regulatory excuses has dealt a deathblow to a century-old legacy of self-reliance in vaccine production and jeopardized the Indian immunization programme,” said a public interest litigation, or PIL, filed with the Supreme Court, which issued a notice to the Centre.
After the closure, the government’s vaccine procurement cell placed orders with private firms to meet requirement for 2008-09. The parliamentary report says, “In most cases, the vaccine requirement exceeds the amount of order placed with firms”.
India’s UIP consists of six primary vaccines—tetanus (TT), diphtheria, pertussis tetanus (DPT), bacilli calmette guerin (BCG) for tuberculosis, diphtheria and tetanus (DT), measles and oral polio vaccine (OPV). These three units produced DT, DPT, TT and BCG.
“By closing these units, the government has put the entire immunization programme at risk,” said Y. Madhavi, senior scientist at the National Institute of Science and Technology.
A consultant immunologist formerly with an international agency working in one of the affected states said the shortage of essential vaccines had, in fact, started a few months before the institutes were closed.
“We were warned by the state that there would be vaccine shortage and it would get worse. This was confirmed when the units were closed in January. By May, essential vaccines started falling short in many districts. In fact, in one district in West Bengal, there was no DPT for six months,” the consultant said, asking not to be identified.
The PIL also argues that the “government also had the option of suspending only exports till the PSUs became GMP-compliant and meet the huge indigenous demand rather than suspending production altogether, especially since there was no complaint on the product quality of the vaccines produced in those PSUs”.
But former drug controller M. Venkateswarlu, who had issued the suspension orders, said this was not an option.
“These three units were not exporting vaccines. Initially, WHO did not inspect these units at all since they were in the public sector. But when they did, it was found that the units did not comply with GMP. We were given a warning by WHO to either take action on the units or face with deregistration of the national regulatory authority,” he said. This would have led to WHO stopping all procurement of Indian drugs for its global supply, implying a hit of Rs1,500 crore to Indian drug exports.
People associated with the institutes say they weren’t given a chance or time to upgrade to meet GMP requirements.
“In December 2006, all three institutes were given directives to comply with GMP. But by November 2007, this idea was changed. Complying with GMP takes time, but instead of encouraging the institutes, the government was not helping at all,” said a senior official at one of the vaccine units who didn’t want to be named.
The Centre had planned to produce the essential vaccines at the proposed state-run Vaccine Park near Chennai, supposed to come up in 2011.
“The government has to think about how it will meet the vaccine requirements in these three years. The private sector is interested in combination vaccines, which are not only more expensive, but we are not even sure of their efficacy,” said Madhavi. “It appears that by killing these institutions and affecting the immunization programme, the private industry will benefit.”
Graphics by Paras Jain / Mint