Drug inspectors are planning to check Indonesia’s vaccine producing enterprise PT Bio Farma for possible contamination of polio vaccine, which threatens to bring the disease back
India's hard-fought victory against polio is at risk as 1.5 lakh contaminated vials of a polio virus strain are suspected to have entered the government's immunisation programme.
India eradicated the highly-infectious viral polio years ago, with the last reported case registered in 2011. However, drug inspectors are planning to check Indonesia’s vaccine producing enterprise PT Bio Farma, to decode the contamination of some batches of a polio vaccine which may bring back the disease in India.
Bio Farma supplies the key raw materials used by Indian manufacturers that make polio vaccines in oral forms. This medicine carries weakened polio viruses to build immunity in people against the disease.
An official from the Central Drugs Standard Control Organisation (CDSCO) told Livemint that four drug inspectors will travel to Indonesia to inspect the company. “PT Bio Farma provides the key starting material — KSM to companies here to prepare the vaccine. We were going to leave on October 29, but we have advanced the trip. The proposal is pending approval from the ministry,” he added.
Where did it start?
The news of this contamination surfaced on September 29 when vaccines made by Ghaziabad’s Bio-Med Pvt Ltd were found to have type 2 strain of polio.
It is interesting to note that the current polio vaccines do not protect against type 2 strain anymore as it was eradicated a long time ago. Vaccine producers were asked to remove its traces from the vaccines and destroy their stock.
Polio vaccines were called trivalent vaccines as they had three strains of viruses — type 1, type 2 and type 3 (also called P1, P2 and P3), and P2 was withdrawn from the vaccines worldwide.
The virus was found in some of the batches of polio drops given to children under the government-run immunisation drive. One vial of the vaccine has 20 doses and 50,000 such compromised vials are believed to be used in Uttar Pradesh and Telangana.
Sylvia Karpagam, a public health expert in Karnataka told the paper that this contaminated vaccine has put many in danger of getting vaccine-derived polio. She added that the virus can mutate and no one knows what form it will take.
In India, there are four major manufacturers of the bivalent vaccine—Bio-Med, where the tainted medicine surfaced, Bharat Biotech International, Panacea Biotec, government’s Bharat Immunological and Biologicals Corp (Bibcol) and Mumbai-based Haffkine Bio-Pharmaceutical Corp.
The regulator is trying to find out if the companies retained P2 strain despite government’s order of 2016 to destroy it completely.
The managing director of Bio-Med was arrested on September 29 after an FIR was filed by CDSCO and was released on bail later. Inspectors have been in and out of Bio-Med plants ever since.
An official from the regulatory body said that the company was not following good manufacturing practices to the full extent.
Why further testing didn’t help
Before any vaccine is sent across the country for use, it is mandatorily tested by the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh. The questionable batches were manufactured in March 2018 and sent to CDL.
The testing, however, is done under the assumption that the manufacturer has provided details of all that is in the vaccine, and only tests those. For example, if the label mentions P1 and P3 stains, the lab would only test these and not P2.
CDL Kasauli director Arun Bharadwaj told Mint that this is the protocol that is followed. “The testing standards are set by the Indian Pharmacopeia Commission (IPC), an autonomous institution of the Ministry of Health and Family Welfare. All samples are tested for their potency as per the label claim” he added.
The lab officials, justifying the reason for such a protocol, said that if the lab started testing for everything suspecting the batches and test vaccines, the process would be so time-consuming that no medicine would ever reach the market.
The CDL was established by the government to ensure the safety and efficiency of the vaccines and antisera produced, distributed and imported in India.
Karpagam also said that money invested in India’s successful polio campaign will be a waste if regulatory mechanisms and quality control measures are not top notch.However, Dr Raj Shankar Ghosh, deputy director, vaccine delivery and infectious disease at Bill and Melinda Gates Foundation, told the paper that the current status, children are protected and there is no immediate threat of an outbreak. “India has a robust surveillance programme and it must be continued,” he added.