Context

The World Health Organization (WHO) has mandated to take steps against substandard and falsified medical products, which have led to the death of at least 300 people, most of them children namely in Gambia, Uzbekistan and Indonesia.

What was the reason for death of Children? (A Case Study)

• The syrup was found by WHO to be adulterated with diethylene glycol (DEG) and ethylene glycol. 
• These chemicals are toxic to humans, and can result in abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, and altered mental state.
• It can also lead to acute kidney injury that can prove fatal in children.

What did the WHO say?

• The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India.
• They failed the test as they have unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, the global health agency stated. 
• All four syrups include; Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – are made by Haryana-based Maiden Pharmaceuticals.

What are the present Drug regulations in India?

Drug regulation in India is a complex process managed by law, mainly the Drugs and Cosmetics Act of 1940, and by multiple ministries, including the Ministry of Health and Family Welfare. The law creates a web of regulatory authorities to govern the process at both the central and the state level.

At Centre level:

• At the central level, the Drugs and Cosmetics Act, 1940, has created the Central Drugs Standard Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is the key regulatory authority, acting under the advice of the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
• CDSCO operates through zonal offices spread across the country, which have designated roles in drug regulation, such as inspections, recalls, and market surveillance.
• CDSCO also has a role in overseeing the functioning of state authorities involved in drug regulation.

What are the challenges associated with Indian drug regulations? 

• Non-scientific classification of offence: The distinction between minor and major offenses isn’t scientific in India. States do not prosecute dissolution, disintegration, or impurity failures because they deem them minor offense. 
• Liberal punishments: lack of adequate fines and punishment has made the crime of Pharma sectors more prominent.
• Competition between states to boost the Pharma sector: As government of India has made pharma sector under innovation criteria for rankings among states has led it under a competition to establish drugs and pharma industry.
• Interstate variation in the prosecution: The variations among the States’ regulation against drug control and Quality check makes it difficult to analyse the real problem.

What are the reasons behind the lack of drug regulations in India?

• Lack of R&D:The Indian pharma industry faces lack of research components and real time good manufacturing practices.
  • No doubt investment (as % of sales) in research & development by Indian pharma companies increased from 5.3 per cent in FY12 to 8.5 per cent in FY18 but it is still low as compared to US counterparts that invest in R & D 15–20% of their sales.
• Compliance issues and good manufacturing practices:
  • This has somehow always been a problem for the Indian companies. The on-going rumour is that the United States Food and Drug Administration are trying to block the growth of the companies.