India's second vaccine maker to get bad marks and stern words in a World Health Organization (WHO) notice this year has come at a bad time not only for offender Ahmedabad-based Cadila Healthcare, but also for a prequalification system essential to global programs.
The dated notice from the WHO came to light after the company posted a notice on the Bombay Stock Exchange this week that it has deficiencies in manufacturing and clinical practices at its Moraiya plant in regard to the rabies vaccine prequalified by WHO since 2008.
It did not however add that manufacturing was suspended and that all the batches of Lyssavac-N (antirabies vaccine) manufactured after April 2015 inspections were recalled.
The notice comes as the company now has two plants issued warning letters from the U.S. FDA in the past few months. The vaccines operation, part of the broader Zydus Cadila group in May last year said there were plans to launch 10 vaccines domestically, including influenza, typhoid, DPT-Hib, hepatitis A, B, E, Japanese encephalitis, HPV and others.
Earlier this month, another WHO notice carrying a suspension was issued to Mumbai-based Svizera Labs a supplier of TB drugs to WHO as manufacturing quality standards remain unreliable following a September report on operations.
The move hits the prequalification status of the company owned by Mumbai-based Maneesh Pharmaceuticals, a highly sought-after designation by vaccines and medicine makers to be able to sell into global health programs.
Indian firms are major suppliers to global programs run by the United Nations and with quality overseen by WHO, along with contributions to other programs such as the Global Alliance For Vaccines And Immunization and the Bill & Melinda Gates Foundation.
Adding onto the woes, WHO has also noted concern that China-based producers have aided illegal sales of vaccines domestically, casting a shadow on regulatory efforts in the country to inspect and regulate supply chains. That's crucial as Chinese firms also eye WHO prequalification as a way to expand production that would allow a robust supply at home as well.
China has rounded up scores of suspects linked to a case of illegal sales of vaccines in Shandong province in the past week during a 5-year period that netted $88 million.
The sales to clinics and improper handling of supplies, including some past expiration dates, has rocked the China FDA as it attempts to assure the public that a safety and quality push is working to root out flawed products from the market.
While not body blows to global vaccine programs, the cases in the world's two most populated countries and major producers have rippled wider.
- here's the announcement to the Bombay Stock Exchange
- and the WHO notice