29th Feb 2020 : The Mains Editorials Notes : Mains Sure Shot
Question – in context of the loss of many innocent lives due to the consumption of Cold Best-PC cough syrup, suggest the ways these incidents can be prevented from repeating in the future.
Context – The death of 12 children in Jammu.
Why in news?
- 12 children died in Udhampur district of Jammu due to poisoned cough syrup (Coldbest-PC). More are fighting for their life in a hospital. A team of doctors at the Post Graduate Institute of Medical Education & Research, Chandigarh, attributed the deaths to the presence of diethylene glycol in the cough syrup which was consumed by all the dead children. Diethylene glycol is an anti-freezing agent that causes acute renal failure in the human body followed by paralysis, breathing difficulties and ultimately death.
- This is the fourth mass glycol poisoning event in India that has been caused due to a pharmaceutical drug.
- In 1973, there was a similar incident at the Children’s Hospital, Egmore in Chennai that caused the deaths of 14 children.
- In 1986, similar poisoning at Mumbai’s J.J. Hospital caused the deaths of 14 patients who were otherwise on the path to recovery.
- In 1998, 33 children died in two hospitals located in New Delhi due to similar poisoning.
- In all three cases, the manufacturer of the suspect cough syrup, due to negligence or human error, failed to detect and contain the level of diethylene glycol in the syrup, thereby causing poisoning of the patients who consumed it.
The main cause:
- Given the history of deaths related to glycol poisoning the reason that can primarily be attributed for the loss of so many lives is neglect and improper implementation of safety standards.
What should be done?
- Tracking the sold bottles: this should be the first priority.
- There will be plenty of time later to ascertain the cause and prosecute the guilty but the immediate concern for doctors, pharmacists and the drug regulators should be to prevent any more deaths. The only way to do so is to account for each and every bottle of the poisoned syrup that has ever been sold in the Indian market and stop patients from consuming this drug any further. Any patient who has consumed even a spoon of the syrup should then immediately be referred to a hospital for treatment.
- Similar incident: According to the information available on the website of the United States Food and Drug Administration (USFDA), in 1937, when the United States faced a similar situation with glycol poisoning, its entire field force of 239 inspectors and chemists were assigned to the task of tracking down every single bottle of the drug. Even if a patient claimed to have thrown out the bottle, the investigators scoured the street until they found the discarded bottle. This effort was accompanied by a publicity blitz over radio and television.
- Checking neglect: We do not see such public health measures being undertaken here; authorities are simply not communicating the seriousness of the issue to the general public. At most, the authorities in Himachal Pradesh (H.P.), who are responsible for oversight of the manufacturer of this syrup, have made general statements that they have ordered the withdrawal of the drug from all the other States where it was marketed.
- However, there is no transparency in the recall process and information about recalls and batch numbers is not being communicated through authoritative channels.
- There is no public announcement by the Drug Controller General of India (DCGI), which is responsible for overall regulation of the entire Indian market.
- The website of the DCGI, which is supposed to communicate drug alerts and product recalls, has no mention of Cold Best-PC as being dangerous as of this writing.
Need/ Way forward:
- Apart from the urgent need to spread awareness and recall the already sold medicines, there is a need for a solid ‘recall policy’ – One of the key reasons why the DCGI and state drug authorities have been so sloppy is because unlike other countries, India has not notified any binding guidelines or rules on recalling dangerous drugs from the market.
- The 59th report of the Parliamentary Standing Committee on Health as well as the World Health Organization (in its national regulatory assessment) had warned the DCGI on the lack of a national recall framework in India. A set of recall guidelines was drafted in 2012 but never notified into law.
- While a national recall of this adulterated medicine is the immediate need, the administration also needs to quickly identify which other pharmaceutical companies have received the spurious ( harmful) ingredient that was supplied to the manufacturer in H.P. from a trader in Chennai.
- It is very likely that the trader in question marketed the same ingredient to other pharmaceutical companies, who, like the manufacturer at the centre of the present scandal, may have failed to test it for its identity and purity.
- It is important for regulatory enforcement to raid and seize the records of the trader in Chennai and verify its sales.
- Also the people need to check the ingredients before buying a product.
Question – At a time when India has limited its presence in South Asian Association for Regional Cooperation (SAARC) and the ASEAN-led Regional Comprehensive Economic Partnership (RCEP), analyse the suggestions of the former Sri Lankan Prime Minister Ranil Wickremesinghe.
Context – The suggestions.
What is the purpose of regional groupings?
- The original purpose of the South Asian group was to build a platform where bilateral issues could be set aside in the interest of regional growth.
Analysing the suggestions of the former Sri Lankan Prime Minister Ranil Wickremesinghe:
- Decrying the lack of economic integration in South Asia, and the failure of SAARC, as well as BIMSTEC (which includes Bangladesh, Bhutan, India, Myanmar, Nepal, Sri Lanka and Thailand), to engender more intra-regional trade, Mr. Wickremesinghe suggested an even smaller sub-grouping of four countries with complementary economies: India, Sri Lanka, Bangladesh and Thailand, to begin the process of reducing tariffs and demolishing non-tariff barrier regimes.
- The Sri Lankan leader also suggested that with India’s leadership, a more integrated South Asian region would be better equipped to negotiate for better terms with RCEP so as not to be cut out of the “productivity network” in Asia, and envisioned an Economic Integration Road Map to speed up the process.
The government’s position:
- The government has made it clear that talks with Pakistan are strictly off the table, and that a SAARC summit, which has not been held since 2014, is unlikely to be convened anytime soon.
- Second, the government, which has taken a protectionist turn on multilateral trade pacts, is relying more on direct bilateral deals with countries rather than overarching ones that might expose Indian markets to flooding by Chinese goods.
- For any regional sub-grouping in South Asia to flourish, it is India that will have to make the most concessions given the vast trade deficits India’s neighbours have at present, which it may not wish to do.
- However, the overall projection that India’s global reach will be severely constrained unless it is integrated with its neighbours, and tensions with Pakistan are resolved, cannot be refuted. India needs to be more accommodative for the realisation of its ambitions.