News Excerpt:

India's drug regulatory body is in the process of updating the approval procedures for pharmaceutical exports in response to apprehensions raised by international authorities regarding the quality and safety of medications originating from the country.

More About the News: The recent decision involves elevating India’s Certificate of the Pharmaceutical Product (CoPP) to match the standards set by the World Health Organization's good manufacturing practices certification.

Key Points: 

•  The core objective behind the regulatory revamp for pharma exports is to introduce transparency into the system, which includes increased oversight over the quantity and quality of products shipped by Indian companies.
• India’s Central Drugs Standard Control Organisation (CDSCO) serves as the apex regulatory authority for the pharmaceuticals, medical devices, and cosmetics industries, akin to the US’s Food and Drug Administration (FDA).
• The CoPP (Certificate of Pharmaceutical Product) is issued within the framework of the WHO's Good Manufacturing Practices certification scheme. It serves as a crucial document necessary for securing product approval and market authorization when exporting pharmaceutical goods from India. 
• This certificate facilitates international trade by enabling the registration of products in foreign markets. Under the updated guidelines, state governments can issue CoPP certificates to pharmaceutical companies only if CDSCO officials participate in joint inspections.
• As part of the overhaul, the Union government recently assumed sole authority for issuing manufacturing licenses for drugs meant for exports, superseding the states.
• To ensure Indian pharmaceutical companies manufacture quality products, the DCGI has mandated strict adherence to the WHO’s good manufacturing practices guidelines at their production facilities.

Safety and quality concerns persist:

• India, being the largest exporter of generic medicines, has faced repeated seizures of drugs by global regulators, primarily due to safety and quality issues.
• In August last year, the WHO issued an alert regarding a batch of contaminated cough syrup found in Iraq, manufactured by Fourrts (India) Laboratories Pvt. Ltd. The manufacturer and marketer, Dabilife Pharma Pvt. Ltd, failed to provide assurances regarding the product's safety and quality.
• Cough syrups from India have been associated with fatalities in Uzbekistan and Gambia, prompting the Indian government to mandate testing before export.
• Before the WHO’s alert, in April last year, the DCGI revoked or suspended licenses of 18 pharmaceutical companies for allegedly producing substandard drugs.

Strengthening Export: 

• Efforts are also directed towards strengthening India's drug exports, alongside the Pharmaceutical Export Promotion Council (Pharmexcil).
• Due to inconsistencies in certificate formats, foreign drug regulatory agencies find it challenging to authenticate Indian pharmaceutical companies.
• Overseas regulators, such as the Drug Administration of Vietnam, are seeking verification from their embassies. The plan now is to centralize the certificate issuance process.
• Discussions are ongoing regarding allowing manufacturers to supply or divert un-exported quantities of pharmaceutical items with approval from the CDSCO and overseas regulators as wastage in pharma exports incurs significant losses for the country and exporters.

Conclusion:

The move to standardize the CoPP and WHO's certificates is seen positively as it boosts confidence among exporters and foreign regulatory bodies regarding the quality of Indian exports.