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.

New TRAI Regulations

New TRAI Regulations

The Telecom Regulatory Authority of India recently came out with the set of new regulations and tariff order applicable to the channel providers, DTH and cable TV operators with effect from February 1st, 2019. The new rules are Telecommunication (Broadcasting and Cable) Services Interconnection (Addressable Systems) Regulations, 2017 and Telecommunication (Broadcasting and Cable) Services (Eighth)(Addressable Systems) Tariff Order, 2017, which were originally notified in March 2017 and re-notified on 3rd July, 2018, further fixing 31st December, 2018 as the time limit for service providers to migrate to the new framework. This limit was finally extended to 31st January, 2019.

The new regulations, resonating the famous phrase “Customer is the king”, proposes to change the previous scenario whereby the consumers were given an option to pick and choose packages (which contained a myriad of channels grouped under one genre) as per their tastes. The reason for such a shift was an ever-growing annoyance whereby the consumer ended paying for many unwanted channels which were shoved upon the user’s guide feed because of subscribing to these packages without actually being able to watch all of the said channels.

According to the statistics relied on by TRAI, 80% of the consumers watch less than 40 channels out of the 200 or so channels offered to them. Thus, the new framework states that the subscribers will not be pushed with unwanted channels; rather they will have freedom to choose only those TV channels that they want to see and pay accordingly.

Some of few significant changes will be:

  • Service providers have to offer a basic package of 100 free-to-air channels at a base price. The ceiling limit of this package has been fixed at Rs. 130 per month, excluding GST.
  • Pay channels must be offered to customers on ‘a-la-carte’ basis. This entails, a user desirous of watching a particular channel of its choice should have the option to subscribe to that channel alone by paying the price fixed for it, without having to purchase the bouquet of that channel (as a package) with other channels at a higher price.
  • The service providers can offer bouquets/packages of channels. The MRP, though, of a pay channel offered in this bouquet/package cannot exceed Rs.19.
  • Discount offered on a bouquet cannot be more than 15% of the a-la-carte sums of the channels comprised in the bouquet.
  • The sum of discount on television channels and the distribution fee paid by broadcasters to a distributor of television channels cannot exceed 35% of the MRP of the television channel.
  • Television channels cannot be priced differently for different distribution platforms.
  • The MRP of the channels needs to be displayed on the TV screen through the Electronic Program Guide. In case of free channels, it should be indicated so.

For a base price of Rs.130, a customer will get 100 free to air channels, which includes 24 mandatory channels of Doordarshan. Out of the 535 pay channels, the customer has to give options of preferred channels. Over and above the free channels, the customer can choose the pay channels, either on a-la-carte basis or by taking a package offered by the operators. This is likely to bring down the monthly DTH/cable bills of the users.

The new regulations were challenged by the STAR Group and other broadcasters deeming them to be unconstitutional in the Madras High Court first and then eventually in the Supreme Court. But both the courts repelled the challenge whereby the judgment of the Supreme Court (authored by Justice Nariman) held that TRAI intended to regulate tendencies of large broadcasters to force customers to subscribe to large bouquet of channels. The TRAI acted with the objective to ‘facilitate competition and promote efficiency in the operation of broadcasting services so as to facilitate growth in such services and harmonize the interests of the service providers and consumers.’

The TRAI has advised the customers to give their options to the operators. If the option is not exercised by January 31st, pay channels will be disrupted from February 1st and the customer will only get the base package. In cases where annual subscription charges are paid by a subscriber in advance, the already availed plan will continue without charge until the expiry of the lock-in period. However, if the subscriber wishes to switch over to a new package after 1st February, 2019 then the proportional balance amount of existing package as on the date of switch over may be adjusted for the new package prices after 1st February, 2019.

In the end, it is a step in favor of the consumer, as not only do the user get a freedom to personalize his Electronic Program Guide via picking-and-choosing of his desired channels, but also will lead to reduction of his DTH bills due to illogical subscription packages being offered to him at the first place. Furthermore, it will ensue greater competition in the entertainment sector as the channels will be pushed to showcase quality content, and will weed out channels, if any, which are not upto to the standards and tastes of the customer.

Jashan Preet Sidhu

Associate Partner at Aggarwal & Associates

[email protected]

New FDI Policy on E-commerce in India

New FDI Policy on E-commerce in India

The Department of Industrial Policy and Promotion (DIPP) recently released a Press Note (PN) 2 of 2018 by introducing sleuth of additional parameters in the ever growing e-commerce sector under the Foreign Direct Investment (FDI) Policy of India on 26th December, 2018 which will come into effect from 1st February, 2019. To shed some light on the objectives of that policy and to further cast away the doubts settling in the industry regarding the policy, the Government of India (GOI) on 3rd January, 2019 released a clarification on it.

Prior to these amendments, the FDI Policy permitted foreign direct investments in entities engaged in marketplace model of e-commerce with no government approval (via automatic route), and prohibited FDI in entities engaged in inventory based model of e-commerce.  A marketplace model of e-commerce means where an information technology platform of a digital and electronic network is provided by an e-commerce entity, which acts as a facilitator between buyer and seller. On the other hand, inventory based model of e-commerce means an e-commerce activity where inventory of goods and services is owned by e-commerce entity and is sold to the customers directly.

It is evident from the PN 2 of 2018 that government is desirous for better implementation of FDI in the e-commerce sector by introducing a myriad of changes. This includes new regulations relating to inventory control, affiliated sellers, and exclusive arrangements. According to the clarification, the government had received numerous complaints that certain e-commerce marketplace platforms were indirectly engaging in inventory based model. These changes are not really new but simply a clarification for better implementation of existing regulations.


  1. Fair and transparent business practices:

As per the clarification, marketplace entities are required to provide the same suite of services to all sellers under similar circumstances.  Additionally, cashback offers provided to the buyers by group companies of marketplace entities will have to be fair and non-discriminating. PN 2 of 2018 specifies the that service terms offered by the service providers to one or more sellers, but that are not offered to other sellers in similar circumstances, will be deemed to be unfair and discriminatory. But it becomes tedious for the players in absence of any guidelines from the government to determine that whether those two sellers are in similar circumstances or not.

  1. Exclusivity arrangements:

PN 2 of 2018 requires that an e-commerce marketplace entity will not mandate any seller to sell any product exclusively on its platform only. The e-commerce entities cannot enter into agreement for the exclusive sale of products. There is no guidance on how the enforcing authorities would determine whether a seller has been coerced to sell its products exclusively on that platform, or if the seller is choosing to do so voluntarily. For instance, some brands with limited sale in India have made a conscious decision to have an online presence only, so as to be on a better footing to control their operational costs and reduce logistical challenges around pan–India offline distribution network. For them it might make business sense to have an exclusive tie-up with one e-commerce platform.

  1. Control over inventory:

The existing FDI policy provides that e-commerce marketplace entities should not exercise ownership over goods sold on such marketplaces. It also requires that a single seller/group should not account for more than 25 % of the aggregate sales on that marketplace. While e-commerce entities complied with the requirement to not own inventory, there were complaints that some of them exercised indirect control over such inventory through warehousing, packaging and handling arrangements. PN 2 of 2018 has introduced a new provision under which an e-commerce platform will be deemed to exercise control over a seller’s inventory, if 25% or more of such vendor‘s purchases are from e-commerce entity or its group companies. PN 2 of 2018 prohibits the vendor from selling their products on platform of e-commerce marketplace entities, if such e-commerce entity is deemed to have a control over the inventory of a vendor. The regulatory objective behind this is to limit the ability of e-commerce marketplaces to sell products to a vendor on a B2B basis, and thereby control pricing or reduce the inventory carriage risk for the vendors themselves.

  1. Compliance:

PN 2 of 2018 requires an e-commerce entity to furnish a certificate annually, confirming compliance with these guidelines. However, it is hard for the e-commerce entities to provide this certificate because of the unclear compliances related to vendors. These changes will come into effect from 1st February, 2019, by giving the.

In a nutshell, these changes would have a significant impact on the e-commerce sector as the entire sector has less than a month to re-organize itself to comply with the present policy. The Government of the day should have veered off from such drastic changes introduced via this policy and should have been considerate to the fact that these players are now one of the major drivers of the economy. The more apt way should have been to gradually introduce these changes over a long haul so that the players have ample buffer to adapt their business practices in compliance with the policy. These new guidelines could have an impact on the digital payments sector, and the broader financial technology industry, especially vis-à-vis the obligation to adopt a fair and non-discriminatory approach. It will be interesting to see how the e-commerce sector adapts to the multiple regulatory changes with already some discontent brewing from the heavy hitters of the sector.

– Kiranpreet Kaur

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali