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Sansad TV: Perspective- Spurious Drug Menace

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Introduction:

The death of 66 children in Gambia, linked to cough syrups manufactured by an Indian firm, has spurred the government to launch an urgent probe into the matter. Samples of the cough syrups, being blamed for the deaths, have been sent for testing. This after the World Health Organisation raised an alert, linking the deaths in Gambia to the four cough syrups, made by Haryana-based Maiden Pharmaceuticals. The global health body says as per the initial lab analysis, each of the four cough syrups contained unacceptable amounts of diethylene glycol and ethylene glycol, considered to be poisonous compounds. Although the exact one-to-one causal relation of death has not been provided by the UN health agency. India has sought the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc. which will help in further investigation and action. While the probe is on, the incident has certainly put the spotlight once again on quality monitoring and due diligence by companies and the need for stricter regulations.

Tracking the sold bottles:

  • 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 syrupthat 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 syrupshould then immediately be referred to a hospital for treatment.

Experience from USFDA:

  • 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.
  • At most, the authorities in 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 suspect product, although manufactured in H.P., has been sold across the country.

About Central Drugs Standard Control Organization:

  • 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.
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country.
  • It also does the coordination of the activities of State Drug Control Organizations by providing expert advicewith a view of bring about the 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 categoriesof critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
  • Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under Ministry of Health and Family Welfare.
  • The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).

Need for a 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 drugsfrom the market.
  • The 59th reportof 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.
  • In 2016, in a report submitted by me to the Ministry of Health suggesting measures to reform the drug regulatory framework, had pointed out to the Ministry that a national drug recall framework was in urgent need.
  • While a national recall of this adulterated medicineis the immediate need, the administration also needs to quickly identify which other pharmaceutical companies have received the spurious ingredient that was supplied to the manufacturer.
  • 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.

Situations are worse in developed countries:

  • The World Health Organisation (WHO) estimates that one in ten medical products in low-and-middle-income countries is substandard or falsified.
  • A substandard drugmay contain no active ingredient, the wrong active ingredient or the wrong amount of correct active ingredient.
  • They are also laden with impurities, much higher than the acceptable range. The substandard drugsare out there in the market, because the companies producing them, does not follow current good manufacturing practices and take short cuts for profits, and regulators’ poor oversight, in some cases it could be just a case of deliberate overlook.

Conclusion:

  • The incident after incident from manufacturers operating in that state, points to inadequacies in oversight of regulatory authorities there.
  • It is important for regulatory enforcement to raid and seizethe records of the trader and verify its sales.
  • The lackadaisical response of drug regulators in Indiais not surprising. It is the result of a larger lethargy and arrogance that is emblematic of the babudom which is responsible for keeping us safe from unethical practices of pharmaceutical companies.