India has to speed up and strengthen the activities on implementation of national pharmacovigilance programmes as the country’s contribution towards global database for drug safety is very little. A commitment and strong decision in this regard has to be developed by the authorities for the sake of common public, said Dr G Parthasarathi, advisory council member, National Pharmacovigilance Programme of the Union health ministry.
 
He was delivering a lecture on the theme, ‘Medicines’ Safety Monitoring - the Past, Present and Future” at Dr MGR Medical University in Chennai.
 
Though the programme of ADR monitoring was started in the country two decades ago, it is still in the nascent stage and its curve is not marking an upward growth. The health authorities here are depending on the data gathered in other parts of the world to make any regulatory decision. There was an argument that India had very little access to medicines, hence no need of safety monitoring.  

But now, the mindset of the authorities has changed because of the growth of science, and the government started giving due prominence to this area. A separate budget head was also created in the current fiscal for national pharmacovigilance programme, Parthasarathi said adding that the authorities while implementing this programme should learn from the past mistakes and work methodically involving all stakeholders to achieve the result.
 
The second major initiative taken by the union government in this year to this effect, according to him, is that it has identified 12 medical colleges in the country to function as ADR monitoring centres. In Tamil Nadu, Madras Medical College in Chennai is the centre and JIPMER will act as the centre in Pondicherry. In Karnataka, JSS Medical College, Mysore where Dr Parthasarathi serves as HoD for Clinical Pharmacy, is the centre. He is also coordinating these three centres in south India.

Sweden based Uppsala Monitoring Centre (UMC), the international drug monitoring program centre of WHO, is gathering drug safety data from its member countries through its national pharmacovigilance programmes. Currently the centre has 114 member countries from around the world and India became a member in 1989. Every member country has to contribute its safety data to UMC, but India’s share has been very less since it attained membership. According to him, this means that India is yet to start pharmacovigilance programme in the country. Till now, the government has not started funding for the promotion of the science of pharmacovigilance or ADR monitoring, he said.

Later while interacting with Pharmabiz, he said “In the modern practice of medicine we have the advantage of potent pharmaceuticals which we did not have years ago. However, the medications we use are double edged weapons. Though they are meant to do good, they may also do harm to our patient population. Hence it is important to weigh the risk and the benefit associated with the therapy”. While the benefit (efficacy data) comes from the clinical trials or efficacy studies, the risk (safety data) takes some period to accumulate, after the marketing authorization is granted to a molecule and the drug is put to general use. Effective post marketing surveillance is essential to gather the safety data, he opined.

According to him, several players are involved in promoting the safe use of medicines that include regulatory authorities, pharma companies, health care professionals and patient population. Each of these players has a very distinct role to play in advocating safe use of medicines.

Dr B Suresh, president, PCI, M Bhaskaran, director, drugs control, Dr TK Ravi, principal, College of Pharmacy, Coimbatore, J Jayaseelan, secretary, IPA-TN and Y Yousuf, vice-president TN-IPA also spoke on the occasion.