What is India doing to curb Adverse Drug Reactions

According to industry experts Adverse Drug Reactions (ADRs) are estimated to account for nearly 5 to 7% of all hospital admissions. ADRs are responsible for the death of nearly 50 out of every 1,000 patients admitted to hospitals.
It has been found out that in past 50 years over 150 drugs had been withdrawn due to adverse reactions. In India more than 10,000 licensed drug manufacturers operating and producing over one lakh branded and generic formulations, if we consider imported drugs for disease like Cancer, Acute Leukemia, Gaucher, Hepatitis C etc then numbers would be immense.Research on ADR has revealed that infant and elderly people are more susceptible to develop ADR symptoms. In this scenario monitoring the drug dosage and recording the therapeutic and adverse effects of these drugs are very crucial.
Secretary Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Dr. V K Subburaj on Wednesday 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 aegis of PHD Chamber of Commerce and Industry here today, Mr. Subburaj pointed out that in the next 10 years the number of pharma manufacturing units will rise by six times from current level of 12,000 units and it becomes all the more important for India to see that while its drugs manufacturing and their exports registered a manifold increase with no suspicion in their content and quality.
ADRs happen due to multiple reasons as variety of stakeholders are involved in drugs administration and therefore, the time has come when India is required to put in a place a sort of regulatory mechanism that can keep an eye to curb the menace of rising ADRs as the tendency that prevails currently is to hush up such cases.
A pharmacist can play a vital role in monitoring ADR and their expertise in this regard is indispensable, says a report. Unfortunately, situation in India is quite alarming. As per the data available from Pharma Council of India (PCI), over a million qualified pharmacists were registered in 2013. If we do a bit of a calculation it will surprise many to know that the density of pharmacist per capita is just 0.0008, which means there are only 8 pharmacists available for every 10000 people, which is a matter of concern. The role of a pharmacist is not limited to a drug dispenser only. Western countries have already brought pharmacists in mainstream and they are added to task force for advance roles. Most of the qualified pharmacist in India ended up as medical representative or sales executive, it is the responsibility of government and healthcare companies to create new jobs for budding Pharma graduates which are more fitting in today’s challenging environment. A pharmacist is a link between a physician and patient and should be responsible for final check on the safety of drugs.
Another matter of concern is the lack of awareness about ADR among Indian healthcare professionals. Despite improvement of ADR reporting systems in India by launching PvPI, the improvement in ADR reporting rate is reported to have not been up to the mark.
“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 awake to this fact in 1982, we have achieved little progress to contain ADRs. This is because it has not been able to create an effective mechanism to address the issue”, said Mr. Subburaj.
According to him, no definite and effective statistics and estimates are available as to how many cases of ADRs happen each year while in America such statistics are accurate and the system in place, India therefore, needs to emulate such a country to address the issue of ADRs with an effective monitoring system in place.
Later on speaking on the occasion Drug Controller General of India Dr. G N Singh concurred that ADRs is the serious issue and the authorities concerned are in constant touch and consultation process with functionaries of WHO so that protracted deliberations are concluded in which representatives 100 emerging economies assemble here and find out ways and means to evolve a regulatory mechanism to contain the menace of ADRs.
On the suggestion by the expert panelists that the 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 on the suggestion saying Pharma 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 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 the access of healthcare services especially in areas where there is shortage of doctors while the pharmacists are available.
NABH guidelines will also now look at including the role of pharmacists for the accreditation said CEO, NABH Dr. K K Kalra.
Among other who were present on the occasion comprised Chairman, Health Committee, PHD Chamber Mr. Nishant V Berlia and its Secretary General Mr. Saurabh Sanyal.