Health Ministry shuts down critical vaccines: Motives suspect

Reopening a sham? Vaccine units won’t make essentials

SC notice to Ramadoss, Centre over closure of vaccine plants

Rema Nagarajan TIMES INSIGHT GROUP 

New Delhi: The government might have reversed its decision to shut down three public sector vaccine manufacturing units following a public furore, but what’s not known is that these ‘‘revived’’ plants will no longer be asked to make vaccines used in bulk in the immunization programme. Instead, they will make minor vaccines.

The upshot of this sham is that vaccines that are needed in millions of doses every year, will have to be bought from private manufacturers at much higher prices.

Answering a question in the Lok Sabha about the reversal of decision to close down the units, health minister Anbumani Ramadoss listed out the products the units — Pasteur Institute of India in Coonoor, Tamil Nadu, CRI Kasauli and BCG Institute, Chennai — will be manufacturing.

The list does not include DPT, which PII and CRI were earlier manufacturing for the universal immunization programme (UIP).
The BCG Institute, which was the sole supplier of the BCG vaccine, won’t manufacture it any longer.
These PSU vaccine units were threatened with closure ostensibly because they did not comply with Good Manufacturing Practices (GMP) under the Drugs and Cosmetics Act.

The minister informed Parliament that upgradation of facilities will be done at the institutes to make them GMP compliant and they would be manufacturing yellow fever vaccine, anti-rabies vaccine, typhoid vaccine and various sera.

However, he failed to explain why the units cannot go back to being bulk suppliers for the UIP once they are certified GMP compliant. The tearing haste in shutting down the PSUs raised a furore as no alternative arrangements were made for supply of vaccines which led to acute shortage.

Said CPM MP Brinda Karat, who has taken up the issue: “Whose interest is being served by shutting down these PSUs? Already, there have been complaints from 15 states about shortage of vaccine following the shut down of the vaccine manufacturing PSUs. So, the decision to shut them down was determined not by the interest of our children’s health but by private manufacturing interests. It is to provide them with a huge market for vaccines to which they had no access as long as the PSUs were doing the manufacturing.”

Karat added that there has not been a single complaint about the quality of the vaccines being produced in these PSUs and hence the decision to shut them down on the ground that they did not follow GMP seemed suspect.

The health ministry is yet to explain why the government can’t spend money to make the units GMP compliant while it was willing to spend money to buy vaccines at a much higher price from private manufacturers.

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SC notice to Ramadoss, Centre over closure of vaccine plants

Shutdown Led To Shortage And Spiralling Of Prices: PIL

TIMES NEWS NETWORK

New Delhi:Health minister Anbumani Ramadoss may have been able to get away without a political cost for his controversial decision to close down three public sector units manufacturing many life-saving vaccines, but he has run into the SC which on Friday agreed to a scrutiny of the legality and prudence of his decisions.
A Bench comprising CJI K G Balakrishnan and Justice P Sathasivam issued notice to Ramadoss, the Centre and Drug Controller of India on a PIL filed by S P Shukla, former special secretary to family welfare department of the Union government.

The PIL sought a stay on the decision to close down the PSUs and immediate resumption of production of vaccines.

Arguing for petitioners also including NGOs Low Cost Standard Therapeutics, All India Drug Action Network, Society for Scientific Values and Medico Friend Circle, senior advocate Colin Gonsalves clinched the issue by citing the recent report of the Parliamentary Committee on Health, which castigated the minister for his imprudent action that allowed the private manufacturers to hike the price and worse, leading to a shortage in the vaccines.

The three public sector vaccine units — Pasteur Institute of India (Coonor), BCG Vaccine Laboratory (Chennai) and Central Research Institute (Kasauli) — were supplying six essential vaccines as part of government’s universal immunization programme (UIP). These vaccines protect children against six diseases like diptheria, pertussis, tetanus, poliomyelitis, measles, and childhood tuberculosis.

Public interest groups say that a successful vaccination programme is directly dependent on the availability of affordable vaccines in the country. They pointed out countries like Brazil, Thailand and Indonesia have always maintained a strong government presence in drugs and vaccine manufacture to meet their health needs.

Interestingly, the health minister said while replying to a question in Parliament recently that an expert committee under the chairmanship of drugs controller general has decided that Pasteur Institute of India will manufacture therapeutic vaccines like tissue culture antirabies vaccine, and anti sera like anti-tetanus serum, anti-diptheria serum, anti-rabies, thus completely excluding essential vaccines under the government’s UIP. More than a year after the PSUs were closed on good manufacturing practice (GMP) and other related grounds, the ministry is still considering proposals for upgradation of CRI, Kasauli, for GMP compliance.

On January 15 last year, the health ministry had cancelled the production licences of the three vaccine manufacturing public enterprises which was the only institute under ministry to have got ISO 9002 certification for its excellence.

A list of low cost vaccines which have been stopped by the ministry: PII’s most important oral polio vaccines, the DTP-hepatitis-B combination vaccine and a cost-effective vaccine against Japanese encephalitis; Kausali-based CRI’s yellow fever vaccine and vaccines for tetanus and rabies; and the BCG vaccine produced at Chennai. The closure of production of vaccines in the three PSUs seriously threaten India’s health security and biosecurity, especially the children, Gonsalves said repeatedly citing the castigation of the minister’s decision by the Parliamentary committee.

( From TOI )