Regulation on Sub-standard drugs

Context

As per the Information, death of a patient undergoing treatment in Sri Lanka, after being given the Indian-manufactured anaesthetic Bupivacaine.

• Imported Indian drugs are at the centre of a medical storm in Sri Lanka, following cases of medical complications and fatalities.

About

• Details of the news:
  • Transparency International Sri Lanka had filed a fundamental rights petition in the Sri Lankan Supreme Court, challenging the decision of the Cabinet and health authorities to procure drugs from unregistered suppliers.
  • The petition further questioned the national drug regulator’s role in providing a waiver of registration to allow for the swift import of essential drugs.

Gujarat-based Savorite Pharmaceuticals (Pvt) Limited and Chennai-based Kausikh Therapeutics were those suppliers.

• • The Supreme Court of Sri Lanka has granted leave to proceed in the case and suspended imports from these companies.

What are Sub-standard drugs?

• Substandard medicines are pharmaceutical products that do not meet their quality standards and specifications.
• The WHO defines ‘counterfeit’ drugs as ‘medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source’.

Drug regulations in India:

• Central Drugs Standard Control Organisation (CDSCO):
  • It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act of 1940.
  • It works under the Ministry of Health & Family Welfare the National Regulatory Authority (NRA) of India.
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for –
  • Approval of Drugs.
  • Conduct Clinical Trials.
  • Laying down the standards for Drugs.
  • Control over the quality of imported Drugs in the country.
  • Coordination of the activities of State Drug Control Organizations.
• Further CDSCO along with state regulators, is jointly responsible for the grant of licences to certain specialised categories of critical Drugs such as vaccines and sera, etc.

Role of Drug Controller of India: DCGI is the head of the department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India. DCGI also sets standards for the manufacturing, sales, import, and distribution of drugs in India.

 WHO’s Global Surveillance and Monitoring System:

• In 2013, WHO launched the Global Surveillance and Monitoring System to encourage countries to report incidents of substandard and falsified medical products in a structured and systematic format, to help develop a more accurate and validated assessment of the problem.
• The system:
  • provides technical support in emergencies, links incidents between countries and regions, and issues WHO medical product alerts; and
  • gathers a validated body of evidence to more accurately demonstrate the scope, scale and harm caused by substandard and falsified medical products and identify the vulnerabilities, weaknesses and trends.
• Significance:
  • The structured reporting system allows for a fast response to emergencies and the issue of alerts in the most serious cases.
  • It also facilitates in-depth analyses of the medical products most at risk, the vulnerabilities and weaknesses in health systems, the harm caused to public health and the need for investment, training and stronger regulations and standards.

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 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.