New Clinical Trial Rules

New Clinical Trial Rules

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention [defined as per U.S Department of Health & Human Services]. They are the primary way that researchers find out if a new treatment, like a form of drug, or a medical device is safe and effective for the people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Lagging behind the rest.

While a few years ago, India conducted 1.5 per cent of global clinical trials and studies, as per the International Repository of Clinical Trials data, this has now fallen to 1.2 per cent. The data further reported that out of 2,97,101 clinical trials [as on February 13th, 2019], a mere 3,618 trials(~1.2 %) are occurring in India. As per the World Health Organization, India’s population is 1.32 billion (i.e. ~17 % of global population), shares 20 per cent of the global disease burden and yet only 1.2 per cent of global clinical trials are done in India. This is a huge worrying sign for the Government of the day.

What are the new rules?

To abridge these gaps, recently, the new set of clinical trials rules have been proposed, which are likely to be notified in March. The rules will enable fast-track proposal clearances for Indian companies rather than their multi-national counterparts. Indian companies will be provided incentive to start clinical trials and their proposals will be deemed approved in case they do not hear from the Director Controller General of India (DCGI) on the status of their application within 30 days. What this entails is that while the domestic approvals will be fast-tracked, for the multinational companies, on the other hand, the waiting period will be defined mostly at six months in the notified rules. These rules are framed in the hope that the indigenous pharmaceutical companies will jump-start the dormant drug research efforts in the country.

Prior to these, pharmaceutical companies, be it domestic or multinational companies, had no clue as to when their paperwork would be accepted by the office of DCGI. This resulted in confusion, delayed conduction of clinical trials and eventual decrease in general levels of drug research in the pharmaceutical companies as there was no leverage to perform the same. The famed generic pharmaceutical companies had no impetus to carry out research on its own. These new rules would boost the indigenous pharmaceutical research in the country and would help bring more global trials both from domestic and multinational companies.

Compensation clause.

In the new rules, the DCGI has, further, decided to change the compensation clause in case of death or disability presumably caused by the clinical trials. Earlier, the rules had said 60 per cent of the amount would be non-refundable, even if an expert committee at a later stage found the death or the disability was not related to the clinical trial. Now the clause of amount being non-refundable has been done away with.

The current rules which were notified in 2015, provide for compensation to those enrolled in clinical trials according to a set formula, when the applicants were compensated anywhere from Rs. 4 lakhs to Rs. 75 lakhs, and that clause will be continued in the new rules as well. It is worth mentioning that, since 2015, according to Ministry of Health and Family Welfare in pursuance to a report tabled in Parliament, close to Rs. 5 crore has been paid in compensation to those enrolled in clinical trials.

Thus, the new proposed clinical trials rules, ensures that India is treading a path to achieve the Sustainable Development Goal 3, erected by the UN, by giving impetus to the indigenous pharmaceutical companies to carry out drug research. This ensures cheap and effective drugs for ailments where there wasn’t any alternative remedy except the expensive drugs manufactured by multinational companies. This will further boost the medical research eco-system prevailing in the country.

Jashan Preet Singh Sidhu

Associate Partner, Aggarwals & Associates, Mohali.



The principal objective of the criminal law is to protect the society by punishing the perpetrators. However, the courts have often reiterated that no one shall be punished without a fair trial. A person might have even been caught red-handed, and yet he is not to be punished unless he is tried and pronounced guilty by a competent court of law. In dispensation of justice, it is extremely important that not only that justice should be done but also appears to have been done. One more cardinal principal of criminal law which the courts follow is that everyone is presumed innocent until proven guilty beyond reasonable shadow of a doubt by a competent court. Thus, it is absolutely important that a person suspected to be guilty of committing a crime is brought on trial before the competent court.

In India, the law of criminal procedure is mainly encapsulated in Criminal Procedure Code, 1973. It provides the machinery for the detection of crime, apprehension of suspected criminals, collection of evidence, determination of the guilt or innocence of the suspected person. In addition, the Code also delves into certain auxiliary aspects such as prevention of offences Chapter VIII (sections 106-124); maintenance of wives, children and parents Chapter IX (sections 124-128) etc. The Code also controls and regulates the working of the machinery which is set up for investigation and trial of offences.

Hierarchy of Criminal Courts in India

The Supreme Court of India and a High Court of each State have been created by the Constitution and their jurisdictions and powers have been well defined in the Constitution. Apart from the Supreme Court and High Courts, the following classes of criminal courts have been described by Section 6 of the Code:

  1. Courts of Session
  2. Judicial Magistrate of First Class and, in any metropolitan area, Metropolitan Magistrate
  3. Judicial Magistrate of Second Class, and
  4. Executive Magistrates

There are certain special courts catering to the special provisions enacted by a legislative action. For instance, Children’s Court under Juvenile Justice (Care and Protection) Act, 2000, or the courts called as ‘Nyaya Panchayats’ or ‘Panchayati Adalats’ constituted under the different State Panchayati Raj Acts, among others.

For every Sessions Division the State shall establish a Court of Session which shall be presided over by a judge to be appointed (which does not refer to his first appointment) by the High Court. The High Court may further appoint Additional Session Judges and Assistant Sessions Judges to exercise jurisdiction in a Court of Session. The Additional Sessions Judge or the Assistant Sessions Judge exercises the powers of a Court of Session, subject to the limitations as prescribed by law.

In every district (not being a metropolitan area), there shall be established as many Courts of Judicial Magistrate of First Class and Second Class, and at such places, as the State Government may, after consultation with the High Court, may specify. Thus, the power to determine the number of Courts of Judicial Magistrates of either class and their location is left to the State Government since it will have to take into account various administrative and financial considerations.

The High Court, in every district, shall appoint a Judicial Magistrate of the First Class to be the Chief Judicial Magistrate, who is the Head of the Magistracy in that district. His main function would be to guide, supervise and control other Judicial Magistrates in the district. He would also try important cases as well. The High Court may further appoint any Judicial Magistrate of the First Class to be an Additional Chief Judicial Magistrate, and such Magistrate shall have all or any of the powers enshrined upon the Chief Judicial Magistrate as the High Court may direct.

[With respect to a Metropolitan Magistrate- As in a district, every metropolitan area will have almost a parallel set-up of Judicial Magistrate as aforemention.]

Lastly, the High Courts may, if requested by the Central and State Government, confer upon any person who holds or has held any post under the government, all or any of the powers conferred or conferrable by or under the Code on a Judicial Magistrate First Class or Second Class or on a Metropolitan Magistrate, in respect to a particular cases.

Sentences which the Courts may pass

  • A High Court may pass any sentence authorized by law.
  • A Sessions Judge or Additional Sessions Judge may pass any sentence authorized by law, but any sentence of death passed by any such judge shall be subject to confirmation by the High Court. {Section 28(2)}.
  • An Assistant Sessions Judge may pass any sentence authorized by law except a sentence of death or of imprisonment for life or of imprisonment for a term exceeding 10 years.
  • A Chief Judicial Magistrate or a Chief Metropolitan Magistrate may pass any sentence authorized by law except a sentence of death or of imprisonment for or of imprisonment for a term exceeding 7 years.
  • A Judicial Magistrate of the First Class or a Metropolitan Magistrate may pass a sentence of imprisonment for a term not exceeding 3 years, or of fine not exceeding five thousand rupees, or of both.
  • A Judicial Magistrate of the second class may pass a sentence of imprisonment for a term not exceeding one year, or of fine not exceeding one thousand rupees or both.

Initiation of criminal proceedings

Often it is the victim(s) of the crime or person(s) who are aggrieved of the said crime who sets the criminal law in motion. It is in the general interest of the society that perpetrators are detected and punished, and for that to happen, the legal system encourages the citizens to invoke the legal process to achieve this end. Accordingly, under the Criminal Procedure Code, 1973 (CrPC), any person can approach the competent Judicial Magistrate and lodge a complaint regarding the commission of an offence (Section 190 CrPC). The Magistrate may then get the matter investigated further by directing the police to do so, or may have an inquiry made into the case with a view to ascertain that whether there is sufficient ground for proceeding (Section 201 CrPC). If in the opinion of the Magistrate, there lies sufficient ground for moving further into the case, he would issue summons or warrants for securing the attendance of the accused for his trial (Section 204, CrPC). However, if the process is invoked, it is then the responsibility of the complainant to collect evidence and to produce it in the court.

Classification of offences

The CrPC has classified offences into two categories:-

  • COGNIZABLE OFFENCES- {Section 2(c)} offences for which a police officer may, in accordance with the First Schedule or any other law for the time being in force, arrest without warrant.
  • NON-COGNIZABLE OFFENCES- {Section 2(l)} offences for which a police officer has no authority to arrest without a warrant.

In case of the former, a police officer can arrest the alleged culprit without warrant and can investigate into such a case without any orders from a Magistrate. In a cognizable case, it is the responsibility of the State (and the police) to bring the offender to justice. Generally, all serious offences are considered as cognizable. By and large, offences punishable with imprisonment for not less than three years are taken as serious offences.  However, certain offences though serious have been considered as non-cognizable offences. For instance, Offences relating to marriage including bigamy and adultery are punishable with more than five years of imprisonment but, they are more in the nature of private wrongs.

In case of the latter, generally speaking, a police officer cannot arrest without a warrant and furthermore, such officer has neither the duty nor the power to investigate, into such an offence without the authority given by a Judicial Magistrate. [However, under section 42, if a non-cognizable offence is committed in the presence of a police officer, and the person committing so refuses to give his name and address, the police officer can arrest him without a warrant with a view to ascertain his real name and address].As a broad proposition it can be deduced that offences which are not serious and are punishable with less than three years imprisonment are treated as non-cognizable offences. These offences are mostly in the nature of a private wrong, for example, assault, hurt etc. However, again, certain offences which are not punishable with more than three years or more have been made cognizable. For instance, offences against Public Tranquility (covered under Chapter VIII of Indian Penal Code) are punishable with less than three years imprisonment, yet, they have been made cognizable.

Jashan Preet Sidhu

Associate Partner at Aggarwals & Associates, Mohali.