With a view to check problems arising out of uncontrolled use of the drugs in the country, a leading expert from the industry, Raj Vaidya, urged the Indian Pharmacopoeia Commission (IPC) to focus on controlling sale and misuse of medicines along with their adverse drug reaction (ADR) reporting initiative.
Considering the lacunae in the approach of the government in addressing the various issues relating to the sale and misuse of medicines compared to the ADR reporting, he stressed that government needs to gear up and come out with a stronger plan that is inclusive of preventive steps against ADR. In his representation addressed to Dr G N Singh, secretary-cum-scientific director of IPC, he clearly pointed out that though the initiative taken by the IPC to actively promote the Pharmacovigilance Programme of India (PvPI) is commendable, steps are also required to control the reasons that lead to ADRs in the first place.
He stated, “It is really a huge initiative, wherein the government is ostentatiously spending crores of rupees on this programme to increase the network and awareness about ADR reporting in the country. However there is also an urgent need to concentrate on checking and policing the malpractices that result in ADRs. While awareness about ADR reporting is necessary, it would be more important to address other crucial issues in our country which lead to increase in the incidences of ADRs, government needs to realise this and take appropriate steps to control this situation that is aimed at reducing the ADRs rather than just reporting it.”
Vaidya immediate past chairman of IPA CPD, further appealed to Dr Singh who is also the Drug Controller General of India to focus on strengthening the drug regulatory system as well to address this issue, by ensuring more stringent check on the sale and availability of prescription medicines which is still freely available in the market without prescription. Other area that needs policing is on the sale of medicines against the prescription by unauthorised practitioners and quacks alongwith the availability of irrational and hazardous medicines and FDCs in the market.
The DCGI was also requested to take more steps to monitor and ensure that medicines are sold only in the presence of a registered pharmacist which is unfortunately not the case today. Vaidya, a practising community pharmacist from Goa who played a key role in introducing the Good Pharmacy Practice (GPP) including preparation of the GPP training manual in a collaborative project of IPA with DCGI and WHO India Country office, further stressed that regulators need to be more stringent in bringing a stop to the irrational prescribing, improper dispensing, use and consumption of medicines by the chemists and the patients simultaneously.
“Considering the lack of the required regulatory support in many parts of the country, steps are needed to be chalked out to strengthen the regulatory system further so as to tackle these issues. These preventive steps adopted through careful planning would automatically reduce the ADRs and its harm within the country. Most essentially, it is important to involve all the stakeholders and devise a nationwide campaign to address these issues to ensure patient safety through specific budget allocation towards this,” stressed Vaidya.