There is a 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, remarked secretary, department of pharmaceuticals (DoP), Dr V K Subburaj while inaugurating a conference on ‘Pharmacology: R&D for Minimising ADRs and Role of Pharmacists’ under the aegis of PHD Chamber of Commerce and Industry in Delhi recently.

Subburaj pointed that this is needed because the number of pharma manufacturing units will increase six times from current level of 12,000 units over the next 10 years. It therefore becomes important for India to ensure that its drugs manufacturing and exports while registering a manifold increase also qualifies the content and quality of drugs.

He explained that ADRs happen due to multiple reasons as variety of stakeholders are involved in drugs administration. Therefore, the time has come when India is required to put in a place a regulatory mechanism that can detect the menace of rising ADRs.

“America, for example, set out to address this issue way back in 1962, consequently little number of cases of ADRs are reported there. Though, India also woke up to this reality in 1982, we have achieved little progress to contain ADRs. This is because our country has not been able to create an effective reporting and regulatory mechanism to address the issue,” he said.

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

While speaking on the sidelines of the occasion, Drug Controller General of India (DCGI) Dr G N Singh concurred that ADRs is a serious issue. The authorities concerned are in consultation with functionaries of WHO to take up the issue with representatives of 100 emerging economies. This will help find out ways and means to evolve a regulatory mechanism to contain the menace of ADRs.

On the question by the expert panelists that whether pharmacists be allowed to prescribe medicines for ailments of general nature, the DCGI said that the government will view it with an open mind. He also stressed that pharmacy graduates should be employed at district or sub-taluka level PHCs.

He further suggested to classify drugs into three categories i.e. the drugs (OTC) which consumer can take directly from medical store, few limited drugs which could be prescribed/suggested by pharmacists and the specialty drugs prescribed by medical doctors. This will also improve healthcare access in areas where there is shortage of doctors while the pharmacists are available.

On the occasion, CEO, National Accreditation Board of Hospitals (NABH) Dr KK Kalra said, "NABH guidelines will also now look at including the role of pharmacists for the accreditation."