Clinical Trials in India: Regulations No Longer Strangulation
Dr. Milind Antani
Pharma & Healthcare team
Nishith Desai Associates
Manya Tripathi
Pharma & Healthcare team
Nishith Desai Associates
Anay Shukla
Pharma & Healthcare team
Nishith Desai Associates


This article throws light on the journey of authorities in bringing a change in the regulatory framework so that a balance is struck between the concerns of subjects of the clinical trial and the growth and development of clinical trial industry in India

India that was once preferred worldwide for conducting clinical trials due to the cost arbitrage and easy and quick enrolment of subjects in state of the art trial sites saw moved southwards for few years due to certain concerns over regulations The uncertain and cumbersome regulations in the past did deter the globally renowned pharmaceutical companies to choose the road that leads to our country. The authorities, where on one hand have to keep the safety of the patients paramount, cannot afford to keep the growth and development of nation at stake, in such a scenario it is necessary that new amendments are being brought to the regulatory mechanism.

The authorities responsible for the enforcement of the Drugs Act are the Central and the State Governments. The Central Drugs Standard Control Organization (CDSCO), headed by the Drug Controller General of India ("DCGI" ) is primarily responsible for coordinating the activities of the State Drugs Control Organization, formulating policies, and ensuring uniform implementation of the Drugs Act throughout India. The DCGI is responsible for handling matters of product approval and standards, clinical trials, introduction of new drugs, and import licenses for new drugs.

Growing concerns over the clinical research ethics followed in India have trailed the pharmaceutical companies that are involved in clinical trials. These companies that have established themselves globally are motivated to outsource their projects to India for several reasons. Some of the eminent reasons being increasing profits, cheap costs for developing drugs, easy regulatory approvals, easy availability of disease inflicted subjects, less hostile environment cutting the cost of drug development and speeding regulatory approval. Conducting clinical trials in India incurs fifty percent less costs in comparison to the developed nations due to the above stated reasons.

However, the number of clinical trials in India have not increased in the past few years and the Government is trying to take measures to ensure that quality of the trials conducted in India improve and rights and safety of the subjects of the clinical trials are also intact

In spite of the zest and zeal with which authorities have been taking steps, it is not easy to infuse changes in the system of a nation as large as India . A nation so full of complexities that are inherent due to different levels of development in various parts and different layers of society. The people of the country and their good health is of utmost concern for any nation, therefore, their safety cannot be compromised and due measures should be taken so that no exploitation is done, however, it is also necessary that people are provided with the most advanced therapy mechanism.

While it is imperative to be concerned about the safety of the patients, the growth and development and the increase in the count of clinical trials in India cannot be overlooked. It is necessary that the drug development for which clinical trials play a pivotal role is encouraged. Therefore, Itis important that the balanced approach should be taken between how much more additional burden needs to be heaped on the regulators in providing scope for development in comparison to ensuring better patient safety and the growth in the research and development of clinical industry which will give rise to the advancement of pharmaceutical industry.

Journey of regulatory reforms

The Drugs and Cosmetics Rules, 1945 governing clinical trials, particularly informed consent procedures adopted for the clinical trials was brought under the scrutiny and amendments were done to the extent to bring transparency in the system of clinical trials. New Drug Advisory Committees (NDAC) which consisted of experts from Government medical colleges and institutes from all over the country were constituted were created. These committees aimed at ensuring that each and every process, protocol was thoroughly vetted by experts so that no iota of doubt was left in deciding that the research practices adopted for the clinical trials were ethical. However, these procedures gave birth to a new problem as the approval process became lengthy, the process became not only cumbersome but also unpredictable so much so that at one point there was a total stand still in taking approvals.

The flourishing Clinical Trial industry in India received a heavy set-back in 2013, when the Supreme Court of India banned the clinical trials after it was alleged that the multinational drug companies were involved in unethical processes for conducting clinical trials. A petition was filed by a Non -Government Organization alleging that the government had been negligent in its approval and oversight of clinical trials.

The Supreme Court issued notices to the Ministry of Health and Family Welfare, the Indian Council of Medical Research (ICMR), the Drugs Controller General of India (DCGI), the Medical Council of India (MCI) and the State of Madhya Pradesh and issued directions for to take actions and reform the regulations dealing with the clinical trials. It banned the trials till such reforms were brought about in the regulations.

The need to address the patient safety concerns made the regulations cumbersome and un-friendly for the global companies who saw India as their potential base for outsourcing clinical trials.

As a result, the sponsor companies which were earlier eager to come to India now abstained from bringing trials to India as a result the once blooming clinical trial industry had fallen prey to the stringent norms.

In early 2013, the Expert Committee which is a statutory body constituted by the DCGI to formulate policy, guidelines and standard operating procedures for approval of new drugs including biologicals, clinical trials and banning of drugs was announced. This committee was bestowed with a mandate to recommend changes to DCGI which would result in a drug regulatory system for India, It came out with recommendations involving accreditation of investigators and centers engaged in clinical trials, enabling time bound review of applications, restriction on providing compensation in cases like situations where injury is caused due to unrelated reasons, streamlining the process of approving academic trials and setting up a central fund for compensation in such trials etc.

The committee's suggestions included that the cost of medical care of adverse events should be borne by investigator or the sponsor. This cost should be borne regardless of causality to which the patient was assigned. This seems to be a restrictive suggestion however, keeping in mind the limited access of health safeguards that the majority of the population of the country has, the measure seems to be an important step. Also the suggestion for limiting the number of trials per investigator had been negated by CDSCO which has limited the number of trials per investigator to no more than three at a time. Following the recommendations another amendment that has been brought about is with respect to the mandatory audiovisual recording of the informed consent process. While the underlying intention of the legislators is clear, the mandate to implement it does not seem practical for variety of reasons.

While the requirement of consent is necessary to maintain the transparency of the conduct of these trials, the privacy of an individual involved as a subject of trials cannot be overlooked. Many patients, who are otherwise willing to participate in a clinical trial, may be unwilling for such a recording. Moreover, this will also create logistic concerns which will cause undue delay in the process of clinical trial. Informed consenting often happens in settings such as clinical offices, intensive care units, operation theatres, radiology suites, intervention suites etc. To ensure audiovisual recording in many of these settings will pose substantial challenges.

In spite of pitfalls because of the extreme steps taken earlier by the regulators to mould the regulations in one direction, the amendments brought about in the recent past have given the clinical trials in India a new shape .

With the aim to speed up innovation and research in India, by a notification issued in March 2016, the Health Ministry has amended the Drug and Cosmetics Act, making out an exemption for clinical trials conducted at academic institutions from taking the hitherto mandatory permission from the Drug Controller General of India (DCGI). The trial has to be approved by the Ethics Committee. However, the Ethics Committee shall inform the DCGI about the cases approved by it and the cases where an overlap between the clinical trials for academic and regulatory purposes can occur.

This latest amendment to the D & C Act has eased the norms of the clinical trials. Some Public experts said that this could be an issue and can be an impediment towards a more transparent and patient friendly clinical trials. However, this amendment has clarified that the Government is on a never ending spree to foster research and development.

Looking at the need of the hour such a step is a welcome step and can be counted as a feather in the cap of the legislators. However, the buck tends to stop at the fact whether in the process of nurturing the research and development, the patient welfare and transparency of the system is being overlooked. This debate can be a never ending one and needs to be looked under a new light.

If we look at the other facet of the coin this step seems to be a balanced approach as the one of the other major amendments brought about in the clinical trial regime is post marketing surveillance where a pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions In order to maintain the authenticity of the system the amendment clarifies that the system will be managed by qualified and trained personnel and the officer-in-charge for the collection of data would be medical officer or trained pharmacist.

Positive Scenario

India accounts for 20% of the world's disease burden and 16% of the world's population, but less than 1.4% of global clinical trials is done in India. These statistics elucidate the glaring demand of improvement in the regulations of clinical trials. The steps have already been taken in the right direction and it is incumbent upon the authorities to keep walking on the path paved so that the regulations which were once strangulations are developed keeping in mind not only the transparency but also the growth and development of the Industry as a whole.

The series of amendments that have been brought in the past few years though earlier placed the ball in one court, have now started to address the concerns of all the groups. The industry too is looking positively at these reforms and have started looking back at India.

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