Hindi English Translation || Editorial || No time for placebo: On The Gambia deaths and drugs regulation

No time for placebo: On The Gambia deaths and drugs regulation

India has to work harder on its image (छवि, सार्वजनिक प्रभाव) of having an independent drug regulator

India’s apex (शीर्ष, सर्वोच्च) drug regulator (नियामक), the Central Drugs Standard Control Organisation (CDSCO) (केंद्रीय औषधि मानक नियंत्रण संगठन), has barred (stop, block, prevent) Haryana-based Maiden Pharmaceuticals Limited from manufacturing medicinal drugs (दवा). This was after some of the cold-and-cough syrup it manufactured and exported to The Gambia were marked out (निशान लगाना, चिह्न लगाना) by the World Health Organization (WHO) (विश्व स्वास्थ्य संगठन) as being linked to the deaths of 66 children there. The concoctions (मनगढ़ंत, मिश्रण) were apparently (जाहिरा तौर पर, कथित तौर पर) contaminated (दूषित करना, अपवित्र करना) with diethylene glycol (DEG) (a common (chemical) industrial solvent which is responsible for accidental and epidemic poisoning. Diethylene glycol, or DEG, is a chemical that can cause potentially fatal kidney and neurological toxicity) and ethylene glycol that may have caused acute (तीव्र, गंभीर, आलोचनात्मक) kidney failure. The Indian government has said that a full report from WHO, establishing a clear, causal link is awaited (इंतजार करना, अपेक्षा करना, ढूँढ़ना). The Union Health Ministry has constituted (गठित करना, स्थापित करना) a technical committee to advise the Government on its future course of action (plan of action) against the company. The provisions (प्रावधान, अवधि) of India’s Drugs and Cosmetics Act (An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. The primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to prescribed quality standards), in theory (in principle, hypothetically), come down heavily on manufacturers for making adulterated (contaminated, polluted, degraded) drugs, and on gross (flagrant, blatant, glaring, obvious, evident; complete, total) violations (breach, contravention, infringement, breaking, non-observance) of prescribed (determined, fixed, established, formulated, pronounced, required, stipulated) manufacturing practices with imprisonment (incarceration, custody, confinement) up to 10 years and fines up to ₹10 lakh. These provisions have been rarely executed despite (regardless of, notwithstanding, in the face of) multiple instances of DEG poisoning in India. In 2020, cough syrup made by the Himachal Pradesh-based Digital Vision killed 13 children in Jammu and Himachal Pradesh; tests showed the presence of DEG. Other inspections by regulatory bodies found that Digital Vision had violated (contravene, breach, infringe, break, disobey, defy, flout) mandatory (obligatory, required, necessary, compulsory) manufacturing practices that would have ensured drugs were not contaminated with DEG. However, there have been no successful prosecutions (legal action, legal proceeding, legal case), because, as in other instances of adulteration (the process/condition of being spoiled/polluted/made impure), there is little sustained (continuous, constant, steady) follow-up (continuation, development) to prove to the courts that the products were directly responsible for the deaths.

Given (considering, taking into account, bearing in mind) that the deaths in The Gambia have evoked (arouse, induce, spark off, trigger, kindle) an international outcry (protest, complaint, clamour, commotion) — it was highlighted (emphasize, draw attention on, underline, underscore) by WHO and India has a reputation (standing, status, position, image) as a major global supplier of drugs and vaccines (a biological preparation that improves immunity to a particular disease) — there will likely be greater scrutiny (examination, inspection, investigation) of India’s actions. Early responses from India’s health establishment have not been encouraging (supportive, promising, supportive, hopeful), with assurances that the drugs were only cleared for export to The Gambia and not for sale in India. In any case (moreover; whatever happens), this is disingenuous (dishonest, deceitful, duplicitous, double-dealing, two-faced, insincere, false, lying, untruthful) as Maiden Pharmaceuticals, whose products were banned in Kerala earlier and flagged (indicate, identify, point out) for substandard (weak, poor, imperfect, flawed) quality in Tamil Nadu, has marketed the same formulation under different names, and there is no reason to assume that their domestic wares (commodities, goods, products) undergo (be subjected to, come in for, go through) a higher standard of production. In the global market of pharmaceuticals, the pandemic (the worldwide spread of a new disease; The illness spreads around the world and typically affects a large number of people across a wide area) burnished (improve, enhance, augment/make better) the credentials (identities, qualities; achievement, experience, knowledge) of India’s vaccine manufacturers as vital (key, essential, important) to ensuring that the whole world accessed medicine equitably (fairly, impartially). To rise up (come up, rise) the value chain, whether it be vaccines or drugs, India has to work harder at its image of having an impartial (unbiased, non-partisan, disinterested, neutral, fair-minded) and independent regulator that can be trusted internationally as well as (and also, and in addition) domestically.

Courtesy: The Hindu

Important Word List With Meaning

1.drug (noun)

Hindi Meaning - दवा
English Meaning - medicine, medication.

2.regulation (noun)

Hindi Meaning - विनियमन, अधिनियम
English Meaning - supervision, overseeing, monitoring, inspection; control, direction, guidance.

3.image (noun)

Hindi Meaning - छवि, सार्वजनिक प्रभाव
English Meaning - public impression, public perception, profile, persona.

4.regulator (noun)

Hindi Meaning - नियामक
English Meaning - an association that supervises a particular business activity.

5.apex (adjective)

Hindi Meaning - शीर्ष, सर्वोच्च
English Meaning - top.

6.Central Drugs Standard Control Organisation (CDSCO) (noun)

Hindi Meaning - केंद्रीय औषधि मानक नियंत्रण संगठन
English Meaning - The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.

7.mark out (phrasal verb)

Hindi Meaning - निशान लगाना, चिह्न लगाना
English Meaning - define, describe, delineate, outline, separate.

8.World Health Organization (WHO) (noun)

Hindi Meaning - विश्व स्वास्थ्य संगठन
English Meaning - Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable - so everyone, everywhere can attain the highest level of health.

9.concoction (noun)

Hindi Meaning - मनगढ़ंत, मिश्रण
English Meaning - mixture, brew/blend, combination (of different ingredients).

10.apparently (adverb)

Hindi Meaning - जाहिरा तौर पर, कथित तौर पर
English Meaning - reportedly, supposedly, purportedly, ostensibly.

11.contaminate (verb)

Hindi Meaning - दूषित करना, अपवित्र करना
English Meaning - pollute, impair, spoil.

12.acute (adjective)

Hindi Meaning - तीव्र, गंभीर, आलोचनात्मक
English Meaning - severe, serious, critical.

13.await (verb)

Hindi Meaning - इंतजार करना, अपेक्षा करना, ढूँढ़ना
English Meaning - wait for, expect, look for.

14.constitute (verb)

Hindi Meaning - गठित करना, स्थापित करना
English Meaning - form, create, establish, set up.

15.provision (noun)

Hindi Meaning - प्रावधान, अवधि
English Meaning - term, clause, requirement/condition.

 
16.placebo (noun)

English Meaning - it is an inactive substance (with no therapeutic effect) is given to one group of participants in a clinical trial, while the treatment (usually a drug or vaccine being tested) is given to another group.

17.regulator (noun)

English Meaning - The process of testing, developing and marketing of medicines has to regulated by regulator to protect the interests of the public. The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory body. Major regulatory bodies include the Food & Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe.

18.bar (verb)

English Meaning - stop, block, prevent.

19.diethylene glycol (DEG) (noun)

English Meaning - a common (chemical) industrial solvent which is responsible for accidental and epidemic poisoning. Diethylene glycol, or DEG, is a chemical that can cause potentially fatal kidney and neurological toxicity.

20.course of action (phrase)

English Meaning - plan of action.

21.India’s Drugs and Cosmetics Act, 1940 (noun)

English Meaning - An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. The primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to prescribed quality standards.

22.in theory (phrase)

English Meaning - in principle, hypothetically.

23.come down on (phrasal verb)

English Meaning - criticize, censure, reprimand, rebuke, reproach, scold, admonish, reprove, castigate, lambast (harshly).

24.adulterated (adjective)

English Meaning - contaminated, polluted, degraded.

25.gross (adjective)

English Meaning - flagrant, blatant, glaring, obvious, evident; complete, total.

26.violation (noun)

English Meaning - breach, contravention, infringement, breaking, non-observance.

27.prescribed (adjective)

English Meaning - determined, fixed, established, formulated, pronounced, required, stipulated.

28.imprisonment (noun)

English Meaning - incarceration, custody, confinement.

29.despite (phrase)

English Meaning - regardless of, notwithstanding, in the face of.

30.violate (verb)

English Meaning - contravene, breach, infringe, break, disobey, defy, flout.

31.mandatory (adjective)

English Meaning - obligatory, required, necessary, compulsory.

32.prosecution (noun)

English Meaning - legal action, legal proceeding, legal case.

33.adulteration (noun)

English Meaning - the process/condition of being spoiled/polluted/made impure.

34.sustained (adjective)

English Meaning - continuous, constant, steady.

35.follow-up (noun)

English Meaning - continuation, development.

36.given (preposition)

English Meaning - considering, taking into account, bearing in mind.

37.evoke (verb)

English Meaning - arouse, induce, spark off, trigger, kindle.

38.outcry (noun)

English Meaning - protest, complaint, clamour, commotion.

39.highlight (verb)

English Meaning - emphasize, draw attention on, underline, underscore.

40.reputation (noun)

English Meaning - standing, status, position, image.

41.vaccine (noun)

English Meaning - a biological preparation that improves immunity to a particular disease.

42.scrutiny (noun)

English Meaning - examination, inspection, investigation.

43.encouraging (adjective)

English Meaning - supportive, promising, supportive, hopeful.

44.in any case (phrase)

English Meaning - moreover; whatever happens.

45.disingenuous (adjective)

English Meaning - dishonest, deceitful, duplicitous, double-dealing, two-faced, insincere, false, lying, untruthful.

46.flag (verb)

English Meaning - indicate, identify, point out.

47.substandard (adjective)

English Meaning - weak, poor, imperfect, flawed.

48.wares (noun)

English Meaning - commodities, goods, products.

49.undergo (verb)

English Meaning - be subjected to, come in for, go through.

50.pandemic (noun)

English Meaning - the worldwide spread of a new disease; The illness spreads around the world and typically affects a large number of people across a wide area.

51.burnish (verb)

English Meaning - improve, enhance, augment/make better.

52.credentials (noun)

English Meaning - identities, qualities; achievement, experience, knowledge.

53.vital (adjective)

English Meaning - key, essential, important.

54.equitably (adverb)

English Meaning - fairly, impartially.

55.rise up (phrasal verb)

English Meaning - come up, rise.

56.value chains (VCs) (noun)

English Meaning - production, trade and investments are increasingly organised within so-called value chains (VCs) where the different stages of the production process are located across different places. (also known as the supply chain).

57.impartial (adjective)

English Meaning - unbiased, non-partisan, disinterested, neutral, fair-minded.

58.as well as (phrase)

English Meaning - and also, and in addition.