Drug Regulators – the need for their support on National Pharmacovigilance.

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The Central Drugs Standard Control Organisation (CDSCO) and the state drug regulatory authorities have to jointly work to strengthen pharmacovigilance programme in India considering the fact that the country is flooded with huge number of drug formulations according to  Dr V Gopal, HoD and principal, college of pharmacy at the Mother Theresa Post Graduate and Research Institute of Health Sciences in Pondicherry.

Although collection of pharmacovigilance data is the responsibility of the experts and designated officials, encouragement should be provided for this activity by the drug regulators in all parts of the country, he said.

Dr Gopal, who is an expert academician in the area of pharmacovigilance, said the authorities who are authorised to conduct the programme (PvPI) must carry on their vigilant investigation when the drugs are circulated in the market. The pharmacovigilance programme of India will do well and achieve its goal provided all the state drugs control officials support the programme continuously. It is the duty of the CDSCO to involve all the state regulators into the programme.

He said present PvPI is good and encouraging. Those who are engaged in the conduct of the programme and the regulatory officials must always keep in mind that the role of the programme is to provide safe drugs to the patients. There should not be any compromise on the part of safety of the drugs as it is for the overall safety of the whole population. The department of drugs control has to become more vigilant in continuing the programme.

Dr Gopal, opined that if the programme should work well, firstly, the public should be given aware of it. Secondly, it should be made a detailed subject of study in all the courses in pharmacy. He said very significant study and research on the subject is going on in JIPMER in Pondicherry. The pharmacovigilance activities in Tamil Nadu and in Pondicherry are very effective.

It is necessary to give training to all the students of pharmacy in the area of pharmacovigilance. Some institutions in India have already started to train their students in the field. He said the CDSCO is taking actions on adverse drugs reactions or other anomalies found in their investigations. Such activities should go on well without any compromise. Patient safety should be the objective of the pharmacovigilance activity and the regulatory officials must always keep this point in their minds, he said.

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