At least two batches of meningitis vaccines meant for Haj pilgrims have failed quality tests, sending government scrambling for emergency supplies.

The two batches were manufactured by Bio-Med Pvt. Ltd, which was given a one-time permit to produce the vaccine for Haj pilgrims after being barred from manufacturing last year.

The development has left the health ministry mulling an alternative plan to inoculate the more than 200,000 Haj pilgrims bound for Mecca in Saudi Arabia from India. The vaccination is mandatory for those going on the pilgrimage.

Bio-Med has been under scrutiny for providing allegedly tainted polio vaccines and was barred from manufacturing and supplying vaccines in September last year. However, the health ministry gave the company a special one-time permission in June to produce meningitis vaccines as it was the sole manufacturer in India.

Two batches of 90,000 doses each of Bio-Med’s vaccines have failed quality tests at the government’s Central Drug Laboratory at Kasauli.

“It’s strange that the health authorities allowed the company which is already under the scanner to supply them vaccines just to save some money," said a public health expert, requesting anonymity.

The Directorate General of Health Services (DGHS) called an urgent meeting on 5 July to discuss the issue. “It has been learnt from the initial results at CDL that the samples of quadrivalent meningococcal meningitis vaccine from Bio-Med are not giving satisfactory outcome although the final report is awaited," said an internal document of the health ministry. Mint has reviewed the document pertaining to the “Haj matter" circulated on 4 July by a joint secretary. It asks for a “detailed review to examine the necessary alternatives to be carried out to ensure that the procurement of the vaccine is completed timely".

To procure the vaccines, meetings were held by the DGHS on 2 and 3 July where it was decided to carry out “emergency procurement". An email sent to Bio-Med managing director Sarayu Garg went unanswered till press time.

Adults and children over the age of 2 arriving in Saudi Arabia for Haj are required to produce a certificate of vaccination against meningitis issued no more than three years and no less than 10 days before their arrival, along with certificates for other vaccines for polio, seasonal influenza, measles and rubella. Haj will begin on 9 August.

“As vaccination of Hajis is a time-bound matter of international health, closely monitored by ministry of health and family welfare, ministry of external affairs and ministry of minority affairs, any delay in vaccine procurement at this juncture is likely to have a negative impact on the entire Indian Haj pilgrimage," added the document.

A health ministry official said things are under control. “70,000 doses of the vaccines have been procured and supplied to stations for the vaccinations of Hajis. The rest will soon be done". A detailed questionnaire sent to the health ministry on 4 July did not elicit any response till press time.

While Bio-Med sells meningitis vaccine at 250 a dose to the government, importing the vaccines may cost the government 1,500- 2,000 a dose.

“The health ministry is already in talks with the two firms which import these vaccines," one of the people cited above said. Sanofi Pasteur, the vaccines division of Sanofi, is the world’s leading provider of seasonal influenza vaccines.

Meningococcal meningitis causes the membranes that cover the brain and spinal cord to become inflamed. It is a serious public health issue that causes severe illness and deaths in at-risk populations.

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