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DoP recommends foolproof system to curb adverse drug reactions

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India should see that its drugs manufacturing and exports register manifold increase with no suspicion in their content and quality: Dr VK Subburaj

Dr VK Subburaj, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, stressed the need for a foolproof system that can restrict, curb and even eliminate causes leading to adverse drug reactions (ADRs) as their reporting is hushed up or avoided to protect the reputation of hospitals and doctors.

Inaugurating a conference on ‘Pharmacology: R&D for Minimizing ADRs and Role of Pharmacists’ under the aegis of PHD Chamber of Commerce and Industry in New Delhi, Subburaj pointed out that in the next 10 years, the number of pharma manufacturing units will rise by six times from the current level of 12,000 units. Hence, it becomes all the more important for India to see that its drug manufacturing and exports register manifold increase with no suspicion in their content and quality.

“The US for example has set out to address this issue way back in 1962 and consequently a small number of cases of ADRs have been reported there. Though India woke up to this fact in 1982, very little was achieved to contain ADRs. This is because it has not been able to create an effective mechanism to address the issue,” said Subburaj.

According to Subburaj, no definite and effective statistics and estimates are available as to how many cases of ADRs happen each year in India while in the US, such statistics are accurate. India needs to emulate such a country to address the issue of ADRs with an effective monitoring system in place.

Dr GN Singh, Drug Controller General (India) said that ADR is a serious issue. Authorities concerned are in a consultation process with functionaries of WHO. Representatives of 100 emerging economies are trying to find out ways and means for evolving a regulatory mechanism to contain the menace of ADRs.

DCG(I) also said that the government will view it with an open mind. He also stressed on the suggestion saying Pharm D graduate should be employed at district or sub-taluka level PHCs. He has also given a suggestion to classify the drugs into three categories i.e. the drugs (OTC) which consumers can take directly from medical store, few limited drugs which could be prescribed / suggested by pharmacists and the speciality drugs prescribed by medical doctors. This will also improve the access of healthcare services especially in areas where there is shortage of doctors while the pharmacists are available.

Now, NABH guidelines will also look at including the role of pharmacists for the accreditation, said Dr KK Kalra, CEO, NABH.

Among others who were present on the occasion were Nishant V Berlia, Chairman, Health Committee, PHD Chamber and its Secretary General, Saurabh Sanyal.

EP News BureauMumbai

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