Why are Indian drugmakers under the lens?

What are the complaints?

Recently, Gambia declared that from July 1, 2023, it is running strict quality control checks on all pharma products imported from India due to contaminated drugs. This decision was made in response to the deaths of at least 70 children in the Gambia last year who had consumed contaminated cough syrups manufactured in India.

What are the new quality control measures?

The new quality control measures will involve document verification, physical inspection, and quality control testing of all pharmaceutical products imported from India. The MCA has also appointed Quntrol Laboratories Private Limited, an independent inspection and testing company, to issue a Clean Report of Inspection and Analysis (CRIA) for all shipments. An importer will require a CRIA issued by Quntrol to clear their goods at the Ports of Entry in The Gambia.

The MCA’s decision is a significant step in ensuring the safety of pharmaceutical products imported into the Gambia. It is also a warning to Indian pharmaceutical companies that they must adhere to strict quality standards if they want to continue exporting their products to the Gambia and other countries.

Here are some additional details about the quality control measures that will be implemented by the Gambia’s MCA:

• Document verification: The MCA will review all documentation related to a shipment of pharmaceutical products, including the manufacturing license, the WHO Good Manufacturing Practices (GMP) certificate, and the import permit.
• Physical inspection: The MCA will physically inspect all pharmaceutical products to ensure that they are properly labeled and packaged. They will also check the expiry dates and the batch numbers of the products.
• Quality control testing: The MCA will conduct quality control testing on a sample of the pharmaceutical products to ensure that they meet the required standards. This testing will include checking the products for impurities, contaminants, and the correct levels of active ingredients.

What is the role of the Central Drugs Standard Control Organisation?

The Central Drugs Standard Control Organisation (CDSCO) is a regulatory body in India that is responsible for ensuring the safety, efficacy, and quality of drugs and cosmetics.

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

India is a major player in the global pharmaceutical industry, but its reputation has been tarnished in recent years by concerns about the quality of some of its drugs. In order to redeem its reputation, India needs to take a number of steps, including:

• Consolidating its regulatory agencies: India has a fragmented regulatory system, with 36 different drug regulators operating at the state and central levels. This has made it difficult to ensure that all drugs manufactured in India meet international standards. The government should consolidate these agencies into a single, centralized regulator that has the resources and expertise to effectively oversee the pharmaceutical industry.
• Strengthening its inspection and testing regime: The CDSCO, India’s main drug regulator, needs to increase the frequency of inspections of pharmaceutical companies and to conduct more rigorous testing of drugs. It should also make the results of these inspections and tests public, so that consumers and regulators around the world can see that India is taking steps to ensure the quality of its drugs.
• Encouraging innovation: India’s pharmaceutical industry is largely focused on manufacturing generic drugs. While this is an important part of the industry, India also needs to encourage innovation and the development of new drugs. The government can do this by providing financial support to research and development, and by creating a more favorable regulatory environment for new drugs.
• Building partnerships with international regulators: India needs to work with international regulators to share information and best practices. This will help to ensure that India’s drug regulatory system meets international standards and that Indian drugs are accepted in markets around the world.