Health Ministry to soon come out with guidelines on good pharmacovigilance practices for Indian cos


In order to usher in good pharmacovigilance practices in the country towards drug safety, the Central Drugs Standard Control Organisation (CDSCO) and Pharmacovigilance Programme of India (PvPI) will soon come out with a set of exhaustive guidelines on par with the existing global guidelines.

The guidelines will feature pertinent areas like signal detection for risk-benefit evaluation and risk management programmes. Signal management is not compulsory in the present set of guidelines. Risk benefit of the product can be measured properly through signal detection.

This comes at a time when the government has mandated market authorisation holders (MAH) to set up pharmacovigilance (PV) cell in their companies in accordance with the Drugs and Cosmetics Rules, 1945 to collect, process and forward the report to the licensing authority for information on adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MAH in the country through a gazette notification on March 8, 2016.

The drug exporting pharmaceutical companies can set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.

A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with contract research organizations (CROs) specializing in pharmacovigilance function.

Typical activities in PV department are ADR case processing and reporting (electronic or hard copy), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programmes (RMP), literature monitoring for ADR case reports (including local literature monitoring, EU MLM search), training of company employees on ADR reporting, global compliance monitoring, audits and inspections.

The SOPs are expected to cover all pharmacovigilance functions and should be structured comprehensively detailing the necessary steps. Since pharmacovigilance involves global operations, clearly written SOPs ensures consistency, compliance, and quality, clear assignment of roles and responsibilities, uniform performance over multiple users to avoid errors of oral communication.

Over 200 doctors, nurses, pharmacists, healthcare workers and young healthcare professionals have got hands on training in the field of pharmacovigilance. In order to to accomplish the skill development programme in the country under the government’s ambitious Pradhan Mantri Kaushal Vikas Yojana, National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) under the Union health ministry started "Skill Development Programme on Basics and Regulatory Aspects of Pharmacovigilance" from January 2017 onwards.

The programme aims to enhance the knowledge and skill of qualified pharmacovigilance professionals working for ensuring better patient safety as per the requirement of Schedule Y of Drug and Cosmetics Act, 1940. Venue for the programme is Indian Pharmacopoeia Commission, Ghaziabad.

Young pharmacy, medical and paramedical professionals seeking career in pharmacovigilance and existing professionals in pharmacovigilance have been taught by renowned experts from government teaching and corporate hospitals, regulatory authority, WHO, pharmaceutical industries, academic and research institutions.

This will encourage and initiate process of creating a registry of skills, enable and mobilize a large number of healthcare professionals to take up training and acquire requisite skills for employment apart from capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPv) as per the requirement of the schedule Y of D&C Act.

In August 2016, Drug Controller General of India (DCGI) had issued a circular stipulating the deadline at January 1, 2018 for upgrading skill sets of persons employed in their units.

India workforce stands at 3.7% in terms of the National Occupation Standards laid down while it is 97% in South Korea and 50% in China. The developed countries also have a very high rate as the low rate out- weighs the other factors in the economy we cannot compromise on the same.

In Maharashtra, Life Sciences Sector Skill Development Council (LSSSDC) set up under auspices of Ministry of Skill Development has mandated Pollux Life Science Solutions LLP led by Hemant Deshpande to conduct broad based skilling, which begins at pharmacy undergraduate level and concludes with job specific theory and practical training of ten prominent roles that covers 90% of the functions in pharma business.

“Keeping in view the objective of bringing substantial improvement in the quality of pharmaceutical products, it has become imperative that all personnel employed in pharmaceutical manufacturing units shall undergo the certification programs developed by LSSSDC and with effect from January 1, 2018, no person shall be employed in any pharmaceutical/bio-pharmaceutical manufacturing units unless he has obtained a formal degree in the relevant area, or has been certified by LSSSDC or equivalent organization in the area in which he has been deployed,” the DCGI circular then said.

Pharmacovigilance (PV) is a science that relates to detection, assessment, understanding and prevention of adverse affects or any other drug related problem. To track adverse drug reactions (ADRs) in Indian population, Union health ministry launched PvPI which has outreach all over the country but only a small portion of healthcare professionals have formal training in PV.

To better the prospects of pharmacovigilance practice in the country, union health ministry has also issued a circular to all the state drug controllers to give their feedback on new set of draft guidelines on pharmacovigilance (PV), recommendations of which has recently been received at the centre and will be released soon after receiving comments from all the state drug controllers of the country.

“Since state drug controllers are going to play a crucial role in ushering good PV practices in the country based on a set of guidelines, feedback and comments on the new set of draft guidelines from state drug controllers will be the last and final step in consolidating PV guidelines towards drug quality and patient safety,” according to a senior health ministry official associated with the development.  

Union health ministry had recently received recommendations from the concerned stakeholders to take forward pertinent aspects of PV like signal detection for risk-benefit evaluation and risk management programmes with a multi-stakeholder approach..


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