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Context: Recently, a Nigerian health agency has flagged off two drugs — oral paracetamol and another cough medicine — manufactured by companies based in Mumbai and Punjab for being “sub-standard or found to be containing toxins”. This is not the first time that Indian pharma companies have faced allegations of exporting contaminated or substandard drugs, which have led to the deaths of children in several countries.

Details

• Since October last year, Indian pharma companies have been under constant international scrutiny for exporting allegedly contaminated drugs, which have led to the deaths of children.
• Apart from Nigeria, Cameroon also sounded an alarm over another cough syrup reportedly made in India when several children died.
• Sri Lanka called out two drugs manufactured in India linking them to adverse reactions in several patients.
• Most recently, Gambia has declared that from July 1, it is running strict quality control checks on all pharma products shipped into the country, before they leave Indian shores.
  • Gambia had reported deaths of at least 70 children related to a contaminated cough syrup made in India, in December last year.
• Uzbekistan had reported the death of at least 18 children after consuming cough syrup contaminated with high amounts of diethylene glycol (DEG) or ethylene glycol poured in.
• The complaints from across the world about the quality of Indian drugs do not seem to stop.

Common Complaints Against Indian Drugmakers

Data integrity

• This refers to the accuracy, completeness, and consistency of data generated during the manufacturing process. Some Indian firms have been accused of manipulating or fabricating data to hide deviations or failures in quality tests.

Contamination

• This refers to the presence of foreign substances or impurities in the drug products. Some Indian firms have been found to have contaminated products due to poor hygiene, inadequate cleaning, or cross-contamination from other products.

Inadequate investigations

• This refers to the failure to properly investigate and resolve quality problems or complaints. Some Indian firms have been criticized for not taking corrective and preventive actions (CAPA) to address the root causes of quality issues or prevent their recurrence.

Implications For The Indian Pharma Industry

• The Indian pharma industry is one of the largest exporters of generic drugs in the world, with a market share of about 20% in terms of volume. It is also a major supplier of affordable medicines to low and middle-income countries, especially in Africa and Asia.
• The repeated incidents of substandard or contaminated drugs tarnish the reputation and credibility of the Indian pharma industry and erode the trust of the consumers and regulators in its products.
• It exposes the industry to legal actions and penalties from foreign authorities, which can affect its profitability and growth prospects.
• It also jeopardizes the public health and safety of millions of people who depend on Indian drugs for their treatment.

Role of the Central Drugs Standard Control Organisation

• The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority for drugs and medical devices in India, under the Drugs and Cosmetics Act of 1940.
• It is working under the Union Ministry of Health & Family Welfare.
• Approving new drugs and clinical trials in India.
• Laying down standards and guidelines for drugs and medical devices.
• Granting licenses for manufacturing, importing, exporting, and distributing drugs and medical devices.
• Inspecting and monitoring drug manufacturing units and testing laboratories.
• Enforcing quality control and safety norms for drugs and medical devices.
• Coordinating with state drug authorities and other stakeholders.

Regulatory processes for manufacturing, quality control and checks

• The regulatory processes for manufacturing, quality control and checks vary depending on the country where the drugs are sold.

Compliance with Good manufacturing practice (GMP)

• GMP is a set of standards and guidelines that ensure that drugs are consistently produced and controlled according to quality standards. GMP covers all aspects of production, from raw materials to finished products, including equipment, facilities, personnel, documentation, and testing.

Registration and approval

• Before a drug can be marketed in a country, it has to be registered and approved by the competent authority of that country. The registration and approval process involves submitting data on the safety, efficacy, and quality of the drug, as well as undergoing inspections and audits by the regulators.

Post-marketing surveillance

• After a drug is approved and marketed, it has to be monitored for any adverse effects or quality issues that may arise during its use. The drugmakers have to report any serious adverse events or product recalls to the regulators, as well as conduct periodic reviews and studies to ensure the continued safety and effectiveness of the drug.

What does India need to do to redeem its reputation in the global pharma industry?

Strengthen its regulatory system

• India needs to improve its regulatory capacity and oversight by increasing its manpower, infrastructure, training, and funding. It also needs to harmonize its standards and procedures with international best practices and norms.

Enhance its compliance culture

• India needs to foster a culture of compliance among its drugmakers by raising awareness, providing incentives, imposing penalties, and ensuring accountability. It also needs to encourage transparency, ethics, and integrity in data generation and reporting.

Invest in innovation and quality

• India needs to invest more in research and development (R&D) and quality assurance (QA) activities to enhance its competitiveness and credibility in the global market. It also needs to upgrade its technology, equipment, processes, and skills to meet the evolving demands and expectations of customers and regulators.

Conclusion

• The Indian pharma industry needs to take urgent steps to improve its quality standards and compliance with global norms. It needs to cooperate with the regulators and foreign authorities to address the issues and concerns raised by them. The regulators need to strengthen their oversight and enforcement mechanisms and ensure transparency and accountability in their actions. The government needs to provide adequate resources and support to the regulators and the industry to ensure the quality and safety of drugs. Only then can India maintain its position as a global leader in generic drugs, and ensure its contribution to public health and social welfare.

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COMMON DRUG STANDARDS: https://www.iasgyan.in/ias-gazette-magazine/perspectivecommon-drug-standards

PRACTICE QUESTION Q. Which of these is/are the function of the Central Drugs Standard Control Organisation (CDSCO)? 1. To regulate the import, manufacture, distribution, and sale of drugs and devices 2. To conduct clinical trials and post-marketing surveillance of drugs and devices 3. To promote research and development of drugs and devices 4. To provide medical education and training to health professionals How many of the above statements is/are correct? A) Only 1 B) Only 2 C) Only 3 D) All Answer: C Explanation: To provide medical education and training to health professionals is not a function of CDSCO, but rather of the Medical Council of India (MCI).

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