• The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.
  • The new rules will change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country.
  • These rules will be applicable to all new drugs, ethics committee and investigational drugs applicable for human use, bioequivalence studies and clinical trial in India.

About New Rules

Objective:​ To change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country.
Coverage:​ These rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee.
Application approval time:​ It has reduced the time for approving applications to30 days for drugs manufactured in India and 90 days for those developed outside the country. In case of no communication from Drugs Controller General of India(DCGI), the application will be deemed to have been approved.
Local clinical trial:​ The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries to be specified by the Drugs Controller General with the approval of the government.
Safety in clinical trial:​ The new rules will ensure patient safety, as they would been listed for trials with informed consent. The ethics committee will monitor the trialsand decide on the amount of compensation in cases of adverse events.

Existing Rules and Issues

  • Clinical trials in India are governed by the acts: Drugs and Cosmetics Act,1940, Medical Council of India Act, 1956 and Central Council for Indian Medicine Act, 1970.
  • Prerequisites of conducting a clinical trial in India are: Permission from the Drugs Controller General, India (DCGI) Approval from respective Ethics Committee where the study is planned Mandatory registration on the ICMR maintained website
  • 2013 Amendments to the Drugs and Cosmetics Act led to better protection of vulnerable groups but the presence of ambiguous language is a concern.
  • The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects.
  • Sometimes Clinical Research Organisations (CROs) recruit them selectively and exploit their ignorance. Their only reward from the trial is financial.
  • Many times consent of the participants in the clinical trials is not taken.
  • In most cases, the ethics committee is not constituted and people on such committees are not well trained.
  • There is a lack of independence for the ethics committee working.
  • There is a need to register with the Clinical Trials Registry of India for all clinical trials conducted in India. But registration is mostly done for positive trial cases. So there is a lack of transparency.
  • There are no well developed international standards dealing with clinical trials.India is a signatory of the Declaration of Helsinki but that is voluntary in nature and lack regulatory mechanisms.
  • Three-tier approval mechanisms have also led to delays in approval.
  • Collusion between drug companies and doctors.
  • Compensation for participating in research as well as the research-related injury is a major bone of contention these days.
  • Moreover, regulatory failure and unethical clinical trials are also major issues.

Significance of the new rules

  • Near 70 million population in India suffer from rare disorders and many ofwhich still not curable and their treatment is also very high.
  • Moreover, the research in India is more skewed towards non-communicable diseases. So, clinical trials in this field will bring much-anticipated balance.
  • The new rules and are expected to promote clinical research in the country through a transparent process yielding faster approvals.
  • The new rules state that any drug discovered in India, or research and development of the drug has been done in India, and which is proposed to be manufactured and marketed in the country, will be deemed approved for clinical trials within 30 working days by Central Licensing Authority (CLA).
  • In the event that there is no communication from the CLA to the applicant within the stipulated time, then the permission to conduct clinical trial shall be assumed to have been granted.
  • Removal of the compensation clause should be considered as a welcome move for all the subjects participating in clinical trials in India. Earlier there was no clarity and there were long and cumbersome legal hassles which created a question mark on the safety of trials.
  • Besides the above change, the drug companies considering India as a market for running local clinical trials get additional benefits if the drugs are approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US.
  • The DCGI would now accept the data generated outside the country thereby making the process easier and application time shorter.
  • Based on research the total number of clinical trials registered till Q1 2018 in India, the market might grow up to 8.5-9 per cent from 2019-2021 and then may pick up faster (2022-2026 to around >12 per cent, if the rules implemented in 2019, yields results in 2019-20 and saves time and cost for the multinational companies.
  • Foreign companies based out of the US and Europe who have been eyeing China as a trial market are yet to gain confidence and are closely watching the scenario, post the new rule in 2019.
  • Apart from this the new rules will end the unnecessary repetition of trials and speed up the availability of new drugs in the country, lower the cost of drugs and will improve the ease of doing business for drug makers.