The Elusive Culture of Compliance : Ajit Nigam, Business Development Manager, Relsys India Private Ltd.

The Elusive Culture of Compliance

The demand for a medicinal product brings with it the issues of Safety and Efficacy. Regulators can play a pivotal role in monitoring the medicinal product and ensuring compliance with the law of the land. The following article suggests the role IT can play in stemming this issue that puts the life of millions at risk. Increased research and clinical trials in India too, have its own set of problems that may be checked by this method.

The Indian pilgrimage to prosperity comes along with structural reforms in various facets of public life. The great Indian population in its march forward requires apart from food, clothing and shelter, adequate Healthcare.

The fast pace of change in healthcare has brought forth new opportunities and new players. India is not only the fourth largest market by volume but also a hot bed for research and a favorite destination for clinical trials. This metamorphosis in the healthcare Industry also exposes its underbelly. Lack of adequate oversight has resulted in counterfeit, ineffective and unsafe medicines in the market place.

Looking at the brighter side, India has a number of homegrown ethical companies following the global best practices. But, they too are fighting a pitched battle for the consumer’s mindscape with a number of spurious medicine manufacturers. We desperately need to provide the right environment for ethical companies to function and grow so that they can play a much larger role in the world arena.

The problems of counterfeit medicines, unsafe drugs, need to monitor a large number of clinical trials, all, can be solved by the country with its valuable resource pool in Information Technology. Our IT manpower has helped the global community in solving a number of outstanding problems and can definitely play a pivotal role here.

How IT can help

Let us try to examine how IT can change the Life Sciences landscape in the country. The story of development of a medicinal product begins with IT getting involved in selection of a molecule for possible commercialisation. As we move from animal to human trials, we need to ensure that trials are ethical, privacy of the patients protected and adequate safeguards are maintained in the volunteer/patient consenting process.

Clinical Trial Management systems developed by various software vendors play a pivotal role in laying down the best practices in order to increase efficiency and effectiveness. With the increase in number of clinical trials and the need for cost/ value arbitrage, new business models are emerging. These help the emerging Clinical Research Organisations to concentrate on moving up the value chain and to do know- what they know best- Research.

It is critical at this juncture to establish appropriate Regulatory Oversight. Using web based technology a Clinical Trial Registry can be established under Central Drug Authority and a system can be developed which marries the requirement of commercial privacy with that of societal need to know and monitor it. A quick reading of jurisprudence entails that society delegates its rights and authority through the instrumentality of governance.

There is a need for this oversight to be continuous for the health and prosperity of the nation. During the clinical trial process only a tiny sample of population is monitored for safety and efficacy of the medicine. But when the medicine is out in the market there are multiple variables and having regulatory oversight without appropriate use of Information Technology is virtually impossible


Post Authorisation Oversight or Pharmacovigilance as it is popularly called is a function, which is growing.

Naturally the perspective of a regulator is different from that of a commercial enterprise. It is the duty of the organisation responsible for the oversight function to ensure the safety of its citizens. It also needs to ensure that the consumers of the medicinal products are not duped and the laws of the land respected.

The Marketing Authorisation Holder should ensure that he has an appropriate system of Pharmacovigilance in place in order to assume responsibility and liability for his products on the market and to ensure that appropriate action may be taken when necessary.

The Marketing Authorisation Holder should therefore ensure that all information relevant to the risk-benefit balance of a medicinal product is reported to the Competent Authorities and the Agency fully and promptly in accordance with the legislation. Source: Volume 9A of European Medicines Agency

Let us now try to examine how an active Pharmacovigilance program can protect and safeguard the health of Indian citizen. In order to do so, the current regulations have to undergo a dramatic change. The discussion on active Pharmacovigilance has been going on for a few years but nothing has been implemented on the ground.
There is a strong case for Pharmacovigilance to be institutionalised under the constitution like SEBI or TRAI. One could always dovetail it into the existing National Pharmacovigilance Infrastructure. The current infrastructure is composed of various nodes at Peripheral, Zonal, Regional and National Pharmacovigilance Centre. The current working of this set up leaves room for much to desire and it is here Information Technology can play a significant part.

At the regulatory level, one must mandate the reporting of Adverse Events (Side Effects) to be compulsory by all medical and healthcare professionals. Reporting by the consumer will have to remain at a voluntary level. At yet another level one can draw a distinction between medicines undergoing trials and medicines in the market for public consumption, prescription or otherwise. But the fact remains, that the regulation remains a piece of paper unless and until effectively implemented. We need to create what I call a, “Culture of Compliance”. In order to do so we have to ensure Adverse Event Reporting has to be as simple as possible for the healthcare community. It should not be an additional burden but has to be a part of the daily routine.

Plan of action

So how do we do this? There are two types of medical practitioners- Institutional and Independent. Institutional Medical practitioners are the ones who are attached to Hospitals, Medical Colleges, Research Institutes etc. On the other hand Independent medical practitioners are those who have a private practice and may or may not operate out of an established clinic.

At the Institutional level, mechanisms can be set up to collect the Adverse Events at a central level in the Institute, validate the information collected and send to Regional / Zonal Pharmacovigilance Centre. During the course of time it can also be linked to Electronic Health Records of an individual. It is the duty of the Pharmacovigilance centre to send the information received to the manufacturer of medicinal product for assessment of causality resulting in meeting the natural laws of justice.

Researchers from the European Molecular Biology Laboratory (EMBL) discovered a new way to make use of drugs’ unwanted side effects. Similar drugs often share target proteins, modes of action and unpleasant side effects. In reverse this means that drugs that evoke similar side effects likely act on the same molecular targets. They developed a computational method that compares how similar the side effects of different drugs are and predicts how likely the drugs act on the same target molecule.

At the level of Independent Medicinal Practitioner this could be collected and sent to the designated Peripheral centre who would validate the information and send it to Regional / Zonal centre for consolidation and follow up with the Headquarters of the Manufacturer of the medicinal product. The third category of the players in our, “Culture of Compliance” paradigm are the consumers themselves. Direct consumer experiences of Adverse Effects should go to the Zonal/ Regional centre where the authority would ask for comments from the manufacturer.

For a manufacturer of medicinal products there should be a legal obligation to report all Adverse Events related to the products they manufacture or market. This can be easily institutionalised at Company Headquarters and reported to Regional / Zonal authority. With the growth in the number of clinical trials, a Clinical Trial Registry could become a suitable mechanism to capture Adverse Events at an early stage.

Information flow and data mining

One would now wonder how this free flow of information and their consolidation happen. There are a number of software applications available in the market today and this can be used to aid this process. The applications have global best practices built-in and can be used on plug and play basis. The international council for harmonisation has developed the E2B Standard for transmission of data, which can be suitably used. With the advent of Web-based applications, one could use the power of Internet to safeguard the health of the Indian consumer. With this giant leap of faith, we could be at a cutting edge. Clearly Pharmacovigilance is an idea whose time has come.


I believe that any information to be useful has to be actionable. Once the information is in a consolidated form at the Zonal/Regional centre, one could mine the data for signals using various methodologies. These signals would tell us about the risk profile of a medicinal product within the Region/ Zone. Using the principles of benefit risk assessment, the Zonal/ Regional Authority could take informed decisions related to issuance of warnings, withdrawal of medicines, label changes etc. The true power of information technology comes forth here in its blazing glory.

At the National level, it is again consolidated to get a macro picture across the Indian geography. The role of technology shifts here with a perspective towards Risk Management and planning. It provides credible and ongoing inputs to healthcare policy makers both in Policy planning as well as implementation strategy for National Missions for eradication of Tuberculosis, Polio etc.

The story does not stop here, but goes on by taking care of Adverse Event Reporting obligation to Uppsala Monitoring Centre and India playing its true role in the global life sciences arena.


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