Cases of substandard pharma products: Pharmexcil talking to authorities abroad to retain confidence

New Delhi: Pharma exporters bodies are conducting regular interactions with the authorities of African and Commonwealth of Independent States (CIS) countries to build confidence and ensure continuity of trade, Parliament was informed on Wednesday. These interactions assume significance on the backdrop of two recent incidents of alleged cough syrup adulteration/sub-standard items found in products exported to Gambia and Uzbekistan.

"Indian Missions abroad are having regular interactions with the authorities to retain the confidence within the drug regulatory agencies," Minister of State for Commerce and Industry Anupriya Patel said in a written reply to the Lok Sabha.

To build confidence and also to ensure continuity of the trade, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has led business delegations to African and Commonwealth of Independent States (CIS) countries and had one-to-one discussions with drug regulating agencies and pharma trade associations, assuring them of the quality of Indian generic products, she said.

Pharmexcil is also conducting workshops/training programmes to sensitise the exporters on quality management and to apprise them of the international standards and their compliances.

She was replying to a question about whether the government has undertaken any survey to assess the impact of incidents of cough syrup adulteration/sub-standard items found in products imported from India in the global markets.

The minister also informed that in the case of Gambia, a joint investigation was carried out by Central Drugs Standard Control Organization (CDSCO) in coordination with the State Drug Controller, Haryana against Maiden Pharmaceuticals Ltd, Sonepat (Haryana) and control samples of the drugs were drawn for test and analysis by Regional Drug Testing Laboratory (RDTL), Chandigarh.

RDTL has declared the samples to be of standard quality and negative for both Diethylene Glycol (DEG) and Ethylene Glycol (EG).

However, based on violations observed in goods manufacturing practices, State Drugs Controller, Haryana, issued an order to Maiden Pharmaceuticals Ltd on October 11, 2022, stopping all the manufacturing activities at Sonepat in the public interest.

In the case of Uzbekistan, CDSCO in coordination with State Drugs Controller, Uttar Pradesh, conducted a joint investigation at Marion Biotech Pvt Ltd, Noida and collected drug samples from the manufacturing premises for test and analysis by RDTL.

The manufacturing license of the firm was suspended by State Licensing Authority, Uttar Pradesh, on January 9.

"RDTL, Chandigarh has forwarded the test reports of 30 drug samples so far, wherein 24 samples of drugs/raw material were declared as 'Not of Standard Quality' out of which 22 samples fall under the category of adulterated/ spurious," she added.