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04 Jul, 2020

26 Min Read

Drugs and Clinical Trials Rules, 2019

GS-II : Governance Drugs and Clinical trails

Drugs and Clinical Trials Rules, 2019

Part of: GS-II/IV- Governance and Ethics (PT-MAINS-PERSONALITY TEST)

In NEWS: COVEX and PANTAJLI CASE (BABA RAMDEV)

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.

Features of New Rules

  • The new rules aim to promote clinical research in India by providing for predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
  • New rules have reduced the time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
  • In case of no communication from the Drugs Controller General of India, the application will be deemed to have been approved.
  • Drug Controller General of India will decide the compensation in cases of death and permanent disability or another injury to a trial subject.
  • 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 specified by the Drugs Controller General with the approval of the government.
  • The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
  • It has been mandated that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator.
  • New drugs approved for use in select developed markets will be automatically allowed in India provided global trials includes Indian patients.
  • This waiver would also extend to drugs that receive these marketing approvals even while a trial is underway in India.
  • New rules has removed regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in well-regulated overseas drug markets.

Clinical Trials

  • A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.
  • It is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials where the efficacy and side effects are observed in animals and an estimated drug dose is established.
  • It is important for anyone preparing a trial of a new therapy in humans that the specific aims, problems and risks or benefits of a particular therapy be thoroughly considered and that the chosen options be scientifically sound and ethically justified.

Phases of Clinical Trials

Clinical trials are carried out in four phases. Clinical trials of drugs developed in India have to undergo all four phases of trials in India.

  • Phase I or clinical pharmacology trials or “first in man” study: This is the first time where the new drug is administered to a small number, a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient's body and behaves in the predicted way.
  • Phase II or exploratory trials: During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centers to determine its effect and also to check for any unacceptable side effects.
  • Phase III or confirmatory trials: Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. In this phase, the group is between 1000-3000 subjects. If the results are favorable, the data is presented to the licensing authorities for a commercial license to market the drug for use by the patient population for the specified and approved indication.
  • Phase IV trials or post-marketing phase: Phase of surveillance after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Regulatory Mechanism in India

  • 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

The Central Drugs Standard Control Organisation (CDSCO)

  • CDSCO is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
  • The Drugs & Cosmetics Act, 1940 and Rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
  • It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and well-being of the patients by regulating the drugs and cosmetics.
  • CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure the safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials.
  • It also lays down the standards for Drugs and has control over the quality of imported Drugs in the country
  • It is also responsible for coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about uniformity in the enforcement of the Drugs and Cosmetics Act.
  • Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine etc.

Key Issues with Clinical Trials

  • 2013 Amendments to the Drugs and Cosmetics Act led to better protection of vulnerable groups but presence of ambiguous language is a concern.
  • The big problem plaguing clinical research is the 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 ethics committee is not constituted and people on such committees are not well trained.
  • There is lack of independence for ethics committee working.
  • There is need to register with Clinical Trials Registry of India for all clinical trials conducted in India. But registration is mostly done for positive trial cases. So there is 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 has also led to delays in approval.
  • Collusion between drug companies and doctors.
  • Compensation for participating in research as well as research related injury is a major bone of contention these days.
  • Moreover, regulatory failure and unethical clinical trials are also major issues.

Ethical Considerations

  • The ethical issues in clinical research primarily involves:
    • Protection of Rights
    • Safety of subjects
    • Well being of the research participants
    • Informed consent and Voluntary Agreement of the participant.
    • Maintain privacy of the participant.
    • Accountability and transparency while conducting trials.
    • Research and trial details should be in public domain.

Significance of New Rules

  • Near 70 million population in India suffer from rare disorders and many of which 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 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 upto 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.

Criticism of New Regulations

  • Monopolistic tendencies in the CRO market remains unaddressed.
  • As India has the vast ethnic diversity the need of bridging trials for ethnically diverse populations to check drug suitability population is not addressed.
  • Waiver should be only for drugs required urgently for national emergency.
  • To prove a injury due to the trial is problematic and it is prone to manipulation.

Way Forward

  • To reap the benefits of clinical trials, our objective should be to bring about more clinical research in the country while maintaining high standards to ensure patient safety and accuracy of data.
  • A clinical trial should be planned and conducted by a trained investigator following the latest rules and regulations with meticulous record keeping and reporting.
  • It is crucial to maintain highest standards, as any compromise may jeopardize public confidence and participation in the clinical trials and may ultimately affect the availability of safe and effective products.
  • With digital revolution touching all the major metros and mini-metros, patients can be monitored real time.
  • Compared to markets like Indonesia where commuting is an issue, or African countries where communication is a major problem or Western Europe where the cost of trials are expensive and patients have limited health issues, but language is major barrier; India offers infrastructure, easy policies (in 2019) and the government has propensity to facilitate more companies considering Indian market as a ground for clinical trial.
  • More and more mid and SME in the CRO segment should be incentivised to promote healthy competition and break down the monopoly. This will directly bring down the cost of conducting trials in India.
  • Unless closely nurtured, this industry can lose its way and get entangled in the complexity of trials.

Q. What are clinical trials? What are the issues with respect to conducting clinical trials in India? Present the ethical issues involved.

Source: PIB

Privatisation of Indian Railways

GS-III :

14 routes identified for private trains by Southern Railway

  • The Indian Railway has planned to offer 14 routes of 16 sets of trains in the Southern Railway for which Request for Quotations (RFQs) was issued on Wednesday after giving in-principle approval for public private partnership (PPP).
  • A senior official of the Southern Railway said that the PPP mode, similar to the opening of the airways for private operators, would see Indian railways competing with private train operators.
  • Though the number of train sets have been fixed at 16, the number of trains to be operated on private routes would be decided later, he added.

New Routes

  • The eight routes originating from Chennai are Coimbatore, Kanniyakumari, Madurai, Tiruchi, Tirunelveli, Mumbai, Mangaluru, and New Delhi.
  • Similarly, two routes passing through Chennai would be the Puducherry-Secunderabad and Kochuveli-Guwahati.
  • The two routes to be privatised outside Chennai division are Tirunelveli-Coimbatore and Kanniyakumari-Ernakulam.
  • Two trains with Chennai as destination and to be operated by Jaipur and Howrah clusters are in the route map. In the Jaipur cluster, a private train from Jodhpur to Chennai and in the Howrah cluster, a private train from Howrah to Chennai would be operated.
  • The railway official said though the routes would be privatised, the trains would be operated by the loco pilots and guards of the Indian Railways.

Unions oppose decision

  • Railway employees’ unions have flayed the Centre for having invited bids from private players to operate 105 trains.
  • Southern Railway Mazdoor Union accused the Centre of misusing the COVID-19 lockdown to promote its privatisation policy.
  • “Since we cannot mobilise people for major protests under the lockdown conditions, the Centre is going ahead with its anti-people policies,” according to SRMU Madurai divisional secretary, J.M. Rafi.
  • Already Indian Railway has asked to close down economically unviable branch lines and also to convert hundreds of long-distance passenger trains into express trains.
  • Dakshin Railway Employees’ Union Madurai divisional secretary, R. Sankaranarayanan, said that operation of private trains would lead to manifold increase in passenger fare. Besides, the private players would not entertain concessions for senior citizens, differently abled persons, students and others.
  • He added that three lakh posts lying vacant in Indian Railways would never be filled.
  • He alleged that the newly-introduced rail-hostesses in Delhi-Lucknow Tejas Express that was handed over to a private player were not paid their salaries at all.
  • But, instead the Government was trying to sell the profit-making sectors of the railway system, which would indirectly further weaken the economy of Indian Railways.

Privatisation of Indian Railways

  • After privatisation of the Tejas Express (to be run by the IRCTC), the government is currently in the process of forming a task force to draw a blueprint for handing over operations of as many as 150 trains and a total of 50 railway stations to private operators.
  • The Bibek Debroy committee recommended that the rail industry needs to be liberalized by allowing the entry of private operators to provide services.

Need for the Privatisation of Railways

  • Low Quality of Service, Catering and Punctuality: Indian Railways deserves the credit for serving the largest democracy in the world, but it faces criticism, particularly in case of aspects like service, catering, and punctuality.
  • Low Internal Revenue: The problem of cross-subsidization has severely affected the internal revenue generation of the Indian Railways.
    • Cross subsidization: Money earned through freight traffic is diverted to meet the shortfalls in passenger revenue, and thus the development of freight traffic infrastructure suffers.
  • Increasing Number of Accidents: Repeated railway accidents have further raised questions on government ownership of railways.

Therefore, for long privatisation of railways has been projected as a possible solution to these issues.

Advantages of Privatisation of Railways

  • Improved Infrastructure: Privatisation will lead to better infrastructure which in turn would result in improved amenities for travelers.
    • Currently, Indian Railways is marred by mismanagement in the form of stinking washrooms, lack of water supply and dirty platforms, it is expected that a private company will ensure better amenities.
  • Normalization of prices due to the competition: Improvement in quality of services has to be matched up by a rise in charges paid by the travelers.
  • However, the issue of price rise will be solved when private players are allowed to enter the sector since the move would foster competition and hence lead to overall betterment in the quality of services.
  • Improved Security: Private participation can lead to better accountability and monitoring, which can keep a check on rising accidents in railways.
  • Better Technological Innovation: Private participation can lead to the infusion of modern technology and capacity building of Indian railways.

Disadvantages of Privatisation of Indian Railways

  • Limited Coverage: An advantage of Indian Railways being government-owned is that it provides nation-wide connectivity irrespective of profit.
  • Privatisation of railways would mean the railways will become a profit-making enterprise, this would lead to the elimination of railways routes that are less popular.
  • Thus, the privatisation of railways can have a negative impact on connectivity and further increase the rural-urban divide.
  • Lesser Inclusive: Hike in fares can render the railways out of reach for lower-income groups.
  • Issue of Accountability: The privatisation of Indian Railways is not easy, as it covers every part of India and runs for 24×7 hours.
    • The whole railway system cannot be handled by a single party or coordination will be very difficult if area wise given to private parties.
  • Impact on the Economy: Indian Railways is the backbone of India, it provides low fare transportation to agricultural and industrial trade.
    • Therefore, privatisation of Indian railways shall definitely affect the Indian economy at large.
    • It is difficult to privatize a portion of the railways’ operations as it is strongly vertically integrated.
    • Vertical integration of railways means ownership and maintenance of the rail and associated infrastructure, all is vested under the Ministry of Railways.

Note: In Britain, the railways are privatized but there is no much effectiveness, so Britain is again planning to re-nationalize the railways.

Way Forward

  • The Tejas Express that will be run by IRCTC, is a kind of Pseudo-privatisation.
  • Since IRCTC is a subsidiary of the Indian Railways.
  • Hence, there is not much real privatisation there, to begin with.
  • Therefore, real privatisation will happen when full-fledged private firms bid for various tasks.
  • Privatisation of railways operations will require a new institutional framework where infrastructure will remain as a government's monopoly while there would be a market of service providers.
  • It is important to modernize the railways, so measures must be taken to reimburse the social costs speedily so that resources of the railways is better allocated and facilities are upgraded from time to time.
  • Core Railways functions can be Corporatizied rather than privatized.
    • Corporatization refers to the restructuring or transformation of a state-owned asset or organization into a corporation. These organizations typically have a board of directors, management, and shareholders.
    • However, unlike publicly traded companies, the government is the company's only shareholder, and the shares in the company are not publicly traded.
  • The peripheral function of railways (cleanliness, ticket disposal, traveler’s amenities), must be privatized.

Important Recommendations of the Bibek Debroy Committee

  • Transition to commercial accounting: The process of accounting in Indian Railways is very complicated.
    • The financial statements of Indian Railways need to be re-drawn, consistent with principles and norms nationally and internationally accepted.
  • The non-core function of railways must be privatized: These activities include running hospitals and schools, catering, real estate development, including housing, construction and maintenance of infrastructure, manufacturing locomotives, coaches, wagons and their parts.
  • Expansion of Indian Railways Manufacturing Company: According to Debroy, wagons are already produced by the private sector. Coaches and locomotives could follow. Unless they are freed from 59 their constraints, the existing production units will be unable to face this competition.
  • Encouraging private entry: Private entry into running both freight and passenger trains in competition with Indian railways should be allowed and private participation.
  • Independent regulator: Shift regulatory responsibility from the government to an independent regulator as the private sector will only come in if there is fair and open access to railway infrastructure.

Source: TH

Covaxin 

GS-III :

Covaxin

Part of: GS-III- S&T (PT-MAINS-PERSONALITY TEST)

The Central Drugs Standard Control Organisation (CDSCO) has granted approval to Bharat Biotech to conduct human clinical trials for ‘Covaxin’, making it the first indigenous Covid-19 vaccine candidate to receive this approval.

  • Covaxin has been developed by the company Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). It is an inactivated vaccine manufactured in the company’s Bio-Safety Level 3 (BSL-3) High Containment facility located in Hyderabad (Telangana).
  • The permission was granted after the company submitted results from pre-clinical studies of the vaccine that demonstrated its safety and immune response. Phase I and II clinical trials will start across India in July 2020.

ImpPoints

  • Clinical trials in humans are classified into three phases: phase I, phase II and phase III and in certain countries formal regulatory approval is required to undertake any of these studies.
  • The phase I clinical studies carry out initial testing of a vaccine in small numbers (e.g. 20) of healthy adults, to test the properties of a vaccine, its tolerability, and, if appropriate, clinical laboratory and pharmacological parameters. Phase I studies are primarily concerned with safety.
  • Phase II studies involve larger numbers of subjects and are intended to provide preliminary information about a vaccine’s ability to produce its desired effect (usually immunogenicity) in the target population and its general safety.
  • Extensive phase III trials are required to fully assess the protective efficacy and safety of a vaccine. The phase III clinical trial is the pivotal study on which the decision on whether to grant the licence is based and sufficient data have to be obtained to demonstrate that a new product is safe and effective for the purpose intended.
  • An application for market authorization may be submitted to the National Regulatory Authority (NRA) on the basis of the data from phase III testing and if approved, the vaccine then becomes commercially available in that particular country.
    • The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) of India.
  • According to the World Health Organisation (WHO), out of 200 Covid-19 vaccine candidates, 15 have entered clinical trials.
    • AstraZeneca is the world’s leading Covid-19 vaccine candidate and has reached the final stage in terms of development. It is being developed by researchers at the University Of Oxford (UK).
    • US Firm Moderna’s vaccine (MRNA-1273) will go into phase III clinical trials in July.

Source: TH

Rules applicable in the Contiguous Zone

GS-II :

Rules applicable in the Contiguous Zone

  • Within the contiguous zone, a State has the right to both prevent and punish infringement of fiscal, immigration, sanitary, and customs laws within its territory and territorial sea.
  • Unlike the territorial sea, the contiguous zone only gives jurisdiction to a State on the ocean's surface and floor.
  • Contiguous Zone is 24 nautical miles from the main coastline.

Recently the UNCLOS’s Permanent Arbitration Council has handed over the jurisdiction of Italian Marines in the Enrica Lexie case of shooting Kerala fishermen in India’s Contiguous Zone to the Italy government.

Source: WEB

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