The new DCGI's order reportedly issued on February 20 to the BCG Vaccine Lab demanding a proposal from the unit for the destruction and writing off of the stocks of vaccines lying with the company is likely to be challenged in the court by the director of the unit, it is learnt.
According to him the country is facing a huge shortage of vaccines and the order of the DCGI came even before his appointment was officially notified in the Gazette.
The director of BCG Vaccine Lab was also one of the candidates called for the 'personal talk' by the health ministry in connection with the selection of new DCGI on February 7 this year.
On assuming charge as DCGI, Dr Surinder Singh issued a notice to the sixty year old Vaccine Lab in which it was reportedly stated that the National Regulatory Authority's (NRA) inspection team had found certain non-conformities of GMP norms put forward by WHO in the institute and the products manufactured there could not be used for immunization purposes.
The DCGI wanted a list of products that were lying in the facility and asked the director to submit a plan for the destruction and writing off of the stocks with the institute for further examination.
Vaccines of crore of rupees are in stock in the three vaccine units owing to the closure of the manufacturing facilities. From reliable sources it was known that the DCGI also directed the state drug controllers to inspect the units to find out whether they are engaged in production or not. The units have stopped manufacture of vaccines following the order of suspension of license by the former DCGI, Dr Venkateswarlu on 15th January this year.
But reports say that CRI Kasauli will start functioning of vaccine production soon and the government may reconsider the suspension of license and opt for further operation due to the shortage of vaccines in the country.
"Normally the candidate who gets selection after the interview, becomes a regular DCGI only when his appointment is notified in the Gazette. It occurs only in 3-4 months after the appointment. First of all, the Appointment Committee of Cabinet (ACC) has to approve it, only afterwards it will be published in the Gazette", the director who was also one of the aspirants for the coveted post told Pharmabiz.
Including the present DCGI, six candidates were called for the interview for the 'personal talk' held at the UPSC office in New Delhi on February 7, 2008.
Reliable sources said that the health ministry had decided to stop the vaccine production in the three units long back. On September 11, 2007 in a meeting of all the State Drug Controllers held in New Delhi, in which the directors of the Vaccine Labs were also invited, the Health Secretary had given a version about the upcoming plan of closing the Institutes. Subsequently, in December last, Dr Venkateswarlu issued show cause notices and in January this year issued the suspension orders.