Indian Pharmacopoeia Commission (IPC) released the guidance manual for developing Herbal Monographs and Quality Manual for Pharmacovigilance Programme of India (PvPI). This also includes the phytopharmaceutical drugs.
The guidance was released by ministry of health and family welfare secretary, C K Mishra, during the governing body meeting of IPC at New Delhi last week.
This guidance deals with processes involved in developing quality monographs for botanicals/herbs. In fact IPC has been working for over 10 years to develop objectively assessable quality standards for herbs, processed herbs and herbal drugs with a view to provide monographs to the stakeholders. Now 150 monographs of this area are included in Indian Pharmacopoeia (IP)-2014 and its two Addenda published so far.
The scientists during this process have evolved various standard operating procedures for the monograph development. These monographs included in IP have received wide acceptance globally and some of these now appear in pharmacopoeias of other nations with or without further changes.
The Commission felt the need to share this information to stimulate greater work in this area. There had been criticism that quality monographs on herbs and botanicals that were removed from earlier editions of IP. With the resurgence of use of herbs in healthcare and emerging phytopharmaceuticals as drugs, there was a need to provide quality specifications for them.
Now the IPC is taking the initiative to form a separate working group of scientists for this work at the Commission’s laboratory supported and guided by an eminent expert committee on herbs and herbal product as IP is a regulatory book of standards. The manual compiles the knowledge of the process of developing monographs to help the industry and scientists and other stakeholders working in this area.
The manual covers various steps in the monograph development criteria, SOPs for monograph development, botanical reference substance, phytochemical reference substances (marker compounds), extracts, herbal product monographs, photography of the candidate material of the monograph. It also includes a non-exhaustive list of suppliers who can provide marker compounds.
Other organisations like the Ayurvedic Pharmacopoeia Committee, Indian Council of Medical Research have contributed immensely to this area. The manual acknowledges and provides information on these publications.
The Commission views that the publication of this manual should help in speeding up the research to provide quality herbals including phytopharmaceutical drugs in consumer interest covering a larger number of herbs.
The efforts of the secretary-cum-scientific director, IPC, Dr DBA Narayana, chairman of the Herbals Committee of IPC, Dr Jai Prakash, senior principal scientific officer, IPC and the associated team are noteworthy, pointed out the Commission.
The Quality Manual for PvPI aims to ensure systems, standard operating procedures to perform the various activities. It was prepared by National Coordination Centre (NCC) for PvPI and was approved by its Quality Review Panel.
While speaking on the occasion, health secretary Mishra, stressed the need of a such quality manual in ensuring harmonized systems and procedure to perform all the elements of PvPI.
Central Drugs Standard Control Organisation (CDSCO) and Pharmaco-vigilance Programme of India (PvPI) are jointly framing a set of exhaustive guidelines on par with the existing global guidelines to usher in good pharmacovigilance practices in the country for drug safety.
This comes at a time when the government has mandated the market authorisation holders (MHA) to set up pharmacovigilance (PV) cell in their companies in accordance to 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 MHA in the country through a gazette notification March 8, 2016.
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.
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 programs(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.
The number of SOPs related to pharmacovigilance may vary from few in number to many, depending upon the length and complexity of the processes involved. SOPs ought to reflect the main requirements of the relevant legislation but should also be adapted to the technical and human infrastructure of the company.
List of SOPs for PV Dept involves procedures for collecting the adverse event reports, validating the adverse reaction reports, evaluating the cases for their seriousness, follow up of cases for missing information, expedited reporting, electronic reporting, periodic reports, signal management and risk benefit assessment and response to request for information from regulatory authorities, Interaction between safety issues and product defects, handling of urgent safety restrictions and safety variations, management and use of databases, training, internal audit of the pharmacovigilance system and archiving.
Sources of collection of adverse event reports are health care professionals, consumers, clinical trials, post marketing surveillance studies, regulatory authorities, literature publications, social media, product quality complaints, medical inquiries, pre-clinical research and business partners.
The Indian Pharmacopoeia Commission (IPC) is soon planning to collaborate with the Indian Council of Medical Research (ICMR) institutions to promote new methodologies and research in the area of pharmacovigilance. This move is aimed at strengthening the Indian pharmacovigilence by identifying common grounds or projects that are focused towards bolstering relevant research to ensure the safety of medicines.
To strengthen and enhance their knowledge, IPC will be working with centres that are involved in research or studies in the area of evidence-based medicine or new methodologies using systematic searches of the medical literature and other pharmacovigilance resources. To spruce up its activities, IPC has already identified six ICMR institutions for this purpose, which will soon be recognised as PvPI collaborating centres, it is reported.
Through this initiative, IPC hopes to develop methodology that will aid in the understanding drug safety issues as well as identifying areas of additional research. There is a clear need to integrate new methodologies into pharmacovigilance to ensure best drug safety practices. Especially since it will open up more evidence to evaluate the effectiveness and efficacy of drugs, pointed out Dr V Kalaiselvan.
“We are currently discussing the modalities and area of focus for research activities based on our requirements and priority. Through this collaborative effort we intend to synergise our broad range of experience in pharmacovigilance and pharmacoepidemiology to bolster the country’s PvPI initiative. We strongly feel that such an effort will go a long way in reinforcing drug safety measures when evaluating the efficacy of medications,” he added.
It is understood that research completed through investigations of these new methodologies can be used in future for withdrawal of products; conduct systematic reviews of adverse effects of drug interventions; evaluate reasons for under reporting of adverse drug reactions etc.
Pharmacovigilance Programme of India’s National Co-ordination Committee should consider roping in pharmacy colleges in the country to expand the patient safety reporting, according to Dr Shobha Rani R. Hiremath, principal, Al-Ameen College of Pharmacy.
“The move would generate more evidence based information on safety of medicines and minimize the risk. The need of the hour is to promote rational use of medicines. Currently, only medical college hospitals have dedicated pharmacovigilance cells. It would be better if pharmacy colleges are included in this programme going by the expertise of faculty in clinical pharmacy and pharmacy practice,” Dr Hiremath, told Pharmabiz.
Pharmacovigilance Programme of India’s (PvPI) initial focus has been to sign up all Medical Council of India (MCI) approved medical colleges in the programme pan-India. The effort was to persuade medical practitioners into the reporting of adverse reaction to drugs, vaccines, medical devices and biological products. The healthcare professionals at the ADR (adverse drug reporting) centres in hospitals collect the case reports and tabulate the data. There are efforts to expand the pharmacovigilance programme to all hospitals both the government and private sector.
Dr Hiremath said that with the introduction of Pharm D, there is a closer connect with leading hospitals in the country to be associated with PvPI. The big advantage for these candidates is the clinical knowledge that they gather from these hospital sites. The Pharm D candidates have a better understanding on the drug reactions because of their exposure to a host of clinical subjects like for instance the pharma therapeutics, clinical research, pharmacoeconomics and pharmacoepidemiology.
Al-Ameen College of Pharmacy entered into a memorandum of understanding with the Karnataka’s oldest government medical centre Victoria Hospital and the missionary managed St. Martha’s Hospital, Bengaluru a decade ago. “Our department of pharmacy was one of the peripheral centres of Pharmacovigilance Programme of India with an objective to monitor adverse drug reactions”, said Dr Hiremath adding that students of M Pharm (Pharmacy Practice) and Ph.D. have worked closely with these healthcare providers.
A couple of years ago Al-Ameen College of Pharmacy also entered into a memorandum of understanding with St. Philomena’s Hospital for the conduct of Pharm D programme. “This pact has further given an opportunity where the Pharm D students from 4th, 5th and 6th years are mandated to be in the hospital for projects and internship. Currently, ADR monitoring is being carried out at St. Martha’s Hospital and St. Philomena’s Hospital, Bengaluru,” stated Dr Hiremath.
“There is no doubt that Pharm D programme molds candidates to be better equipped to work in a hospital setting. Therefore, including pharmacy colleges into the Pharmacovigilance Programme of India would expand the patient safety reporting,” stated Dr Hiremath.
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.