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Centre allocates Rs.100 cr for PV project, set to include biovigilance & materiovigilance

Nandita Vijay, Bengaluru
Monday, August 26, 2013, 08:00 Hrs  [IST]

In a major effort to give a fillip to the national pharmacovigilance programme, the Union government has set aside Rs.100 crore for surveillance monitoring of not just drugs but also now intends to  increase the ambit of surveillance from drugs to blood, blood products to biologicals and medical devices. Efforts are also on to set up an anti microbial resistance monitoring cell. The effort is to ensure India has a dedicated data of adverse reactions for drugs, biological grafts, implants and  blood- blood products.

An advisory committee of pharmacovigilance in the country has now proposed to the government that there was a need for bio-vigilance, materiovigilance along with pharmacovigilance and hemovigilance.

The centres which will take on the surveillance of four activities are: Indian Pharmacopoeia Commission for pharmacovigilance,  All India Institute of Medical Sciences (AIIMS) for hemovigilance, National Institute of Biologicals for bio-vigilance and materiovigilance by the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) Thiruvananthapuram. The anti microbial resistance cell could be set up either at the JIPMER (Jawaharlal Nehru Institute of Postgraduate Medical Education and Research) Puducherry or the Nizam Institute of Medical Sciences  Hyderabad.

“The need of the hour is evidence-based policy decision,” Dr Surinder Singh, director National Institute of Biologicals, and member, advisory committee, Pharmacovigilance Committee, government of India and former drugs controller general of India (DCGI) told Pharmabiz.

There is very little information available on the drug biological grafts, implants and blood- blood products. “Although there are efforts where institutes like National Institute of Mental Health And Neuro Sciences (NIMHANS), Bengaluru AIIMS, New Delhi have data base of their patients on drug reactions and blood-blood product issues, we now need to have a systematic record of this information,” added Dr Singh who was in Bengaluru.

“Going by the country’s importance in the healthcare and growing patient population, the government is now keen to look at having a methodological system where data could be accessed for future prevention of adverse reactions. We need to collect and collate the data. The country is home to access to highly qualified scientific teams and healthcare professionals and therefore implementation of the task is not a issue,” said Dr Singh.

Similarly, in the area of anti-microbial resistance, there are scores of cases of tuberculosis and other related infections including the super bug. Therefore, there is need to keep a close watch on the same, he said.


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