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Monthly DNA
04 Jul, 2020
26 Min Read
Paper | Topics | Subject |
---|---|---|
GS-II | Drugs and Clinical Trials Rules, 2019 | Governance |
GS-III | Privatisation of Indian Railways | |
Covaxin | ||
PT Pointer | Rules applicable in the Contiguous Zone |
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
Clinical Trials
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.
Regulatory Mechanism in India
The Central Drugs Standard Control Organisation (CDSCO)
|
Key Issues with Clinical Trials
Ethical Considerations
Significance of New Rules
Criticism of New Regulations
Way Forward
Q. What are clinical trials? What are the issues with respect to conducting clinical trials in India? Present the ethical issues involved.
Source: PIB
14 routes identified for private trains by Southern Railway
New Routes
Unions oppose decision
Privatisation of Indian Railways
Need for the Privatisation of Railways
Therefore, for long privatisation of railways has been projected as a possible solution to these issues.
Advantages of Privatisation of Railways
Disadvantages of Privatisation of Indian 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
Important Recommendations of the Bibek Debroy Committee
Source: TH
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.
ImpPoints
Source: TH
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
India’s torture culture needs to end now By, Ajit Prakash Shah is retired Chief Justice, Delhi and Madras High Courts Context # By now, everyone has heard of the tragic deaths of P. Jayaraj and J. Benicks, a father-son duo in a small town in Thoothukudi. Jayaraj, 58, was arrested by t
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Striking a blow against Assam’s inclusive ethos By, Manoranjan Pegu is a trade union activist based in Delhi. The views expressed are personal Context # The Assam government recently decided to promulgate a law to make the Assamese language compulsory in all schools, both public and p
Streaming for reading By, Brij Kothari is on the faculty of IIM-Ahmedabad and the founder of PlanetRead Revolutionary potential # A national implementation of SLS (Same Language Subtitling) on existing general entertainment content (GEC) on TV and streaming platforms, also known as Over-The
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Legal principles to reduce custodial deaths Part of: GS-II- Governance POLICE REFORMS (PT-MAINS-PERSONALITY TEST) Understanding the background of the problem In wake of custodial deaths in Tamil Nadu, the debate on the Roman dilemma: “Who will guard the guardians” rises
Need for Police reforms in India Part of: GS-II- Governance POLICE REFORMS (PT-MAINS-PERSONALITY TEST) Context: The Police system in India and its sorry state once again came to the fore recently when a father-son duo, namely P Jeyaraj (58) and Fenix (31) respectively, died in Police custody i
Micro Food Processing Enterprises Scheme Part of: GS-III- Economy (PT-MAINS-PERSONALITY TEST) Recently, the Ministry of Food Processing Industries (MoFPI) launched the PM Formalization of Micro Food Processing Enterprises (PM FME) scheme as a part of the ‘A
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