×

UPSC Courses

DNA banner

DAILY NEWS ANALYSIS

GS-III :
  • 29 July, 2020

  • 10 Min Read

The cost of haste: On drugs, vaccines and regulators

The cost of haste: On drugs, vaccines and regulators

Breach of ‘Do not harm’ principle

  • So far-reaching are the effects of COVID-19 that it has harried drug regulatory authorities, usually the most risk-averse within the bureaucracy.
  • ‘Do no harm’ is the driving principle of drug regulation and this is reflected in the thicket of documents and permissions that stand before the average novel drug or vaccine, for a chance at making it to the market.

Compressed timelines

  • However, SARS-CoV-2, while mostly non-lethal, kills across demography and age-groups to confound sophisticated care systems.
  • This has sent a signal to drug companies, biomedical firms and governments to scramble for anything with even the slightest chance of success.
  • It is in this context that regulators, used to long timelines of testing new vaccines or drugs, are now under pressure to facilitate a solution rather than stick to weighing and dwelling on evidence of efficacy and safety.
  • India’s drug regulatory authority as well as the Department of Biotechnology, which also funds vaccine development and drug research, now collaborate on fast-tracking.
  • For instance, if an Indian company has partnered with a foreign one in developing a vaccine, then any trials already conducted by the foreign unit would be considered in allowing Indian companies to avoid repeating them in India.
  • For drugs, those that have been proven to be safe for treating one disease may skip a fresh, large human trial, or a phase-3 trial.
  • Potential vaccines too are now allowed to combine stages of trials — normally, regulators must approve results of each stage — to permit those testing the drug to move to the next stage.
  • The rush to compress timelines, in itself, is no guarantee that a workable vaccine or reliable drug will emerge any faster. Drugs and vaccine-development have historically been expensive because immunology is a complex, eternal struggle with disease, and with high failures.

Need of the hour

  • There have been instances when disease mortality is so high that not offering even a half-baked drug or a vaccine would be unethical.
  • That is a call regulators have to constantly take. But not all emergencies are the same.
  • There is now a situation, as in the case of itolizumab, a psoriasis drug repurposed for COVID-19, where the drug regulator has approved it for emergency use but the COVID-19 task force has expressed its reservations.
  • Such dissonance among experts is unacceptable especially when they all have access to the same evidence.
  • There is a tendency to view COVID-19 vaccine development or a new drug as a ‘race’ in which only the first vaccine to be out matters.

Haste does not aid science.

Source: TH


Anti-Defection Law in India

The Supreme Court of India recently gave a final three-week deadline to the Telangana Assembly Speaker to decide pending disqualification petitions against defecting MLAs under the Anti-Defection Law. What is the Anti-Defection Law? The Anti-Defection Law was introduced through the 52nd Amendment (1985), which added the Tenth Schedule to the

Rat-Hole Mining

A major disaster unfolded in East Jaintia Hills, Meghalaya, when at least 18 workers died following an explosion in an illegally operating rat-hole coal mine. This incident highlights the continued prevalence of rat-hole mining despite bans imposed by the National Green Tribunal (NGT) and the Supreme Court of India. Rat-hole mining is driven

India’s Aviation Sector

India’s aviation sector has grown rapidly, becoming a major economic success story. However, regulatory oversight has not evolved at the same pace. Data-driven monitoring of fares and market behavior is essential to ensure fair competition, prevent market abuse, and shift from reactive crisis management to proactive regulation. Challen

Federalism in India

Recently, a high-level committee on Union–State relations submitted its first report to the Government of Tamil Nadu. The report examines the distribution of powers and responsibilities between the Union and the States, highlighting ongoing debates regarding the balance between central authority and state autonomy. This discussion is clos

India–UAE Economic Partnership

The relationship between India and the United Arab Emirates has evolved from a traditional energy-based partnership into a comprehensive economic and strategic relationship. Over the years, strong political trust, growing trade, and expanding investments have transformed bilateral ties into a diversified economic corridor. The economic partnership

DNA

22 Mar,2026

Toppers

Search By Date

Newsletter Subscription
SMS Alerts

Important Links

UPSC GS Mains Crash Course - RAW