Centre rejects Amritsar firm plea to sell Remdesivir locally

GS Paul

Tribune News Service

Amritsar, May 3

The Central Drugs Standard Control Organisation (CDSCO) has shown its inability to ‘relax’ norms when it comes to manufacture and sale of anti-viral Remdesivir in the domestic market.

Can’t go beyond norms, says govt

To manufacture Remdesivir and import the Active Pharmaceutical Ingredients, the firm would need to obtain New Drug permission under the drug rules, 1945. This is a time-consuming and cumbersome process. — Central Drugs Standard Control Organisation

Company approaches State authorities

I am pained to see people dying due to Remdesivir shortage. Now, I have approached the Punjab Food and Drugs Administration to at least cater to local patients. My firm has the capacity to produce 50,000 injections a day. — Ramesh Arora, MD, Kwality Pharmaceuticals

Remdesivir is the first drug to show improvement in Covid patients during clinical trials. However, it witnessed an acute shortage. The 100 mg vial of the drug costs around Rs 3,000-Rs 3,500, but the vendors have been black-marketing the drug six times its price. As there has been a sudden spike in its demand, the Centre has restricted the export of Remdesivir injection and importing Remdesivir Active Pharmaceutical Ingredients (API).

To curb it, Amritsar-based Kwality Pharmaceuticals had approached the CDSCO, seeking exemption in norms by breaking the patent reserved with the US-based Giload Sciences for its manufacture and sale in India.

Turning down the firm’s submission, the CDSCO has conveyed that for manufacturing Remdesivir and importing the API, the firm would need to obtain New Drug permission under the drug rules, 1945. This is a time-consuming and cumbersome process. At present, seven firms in the country — Mylan, Hetero, Jubiliant Life Sciences, Cipla, Dr Reddy’s, Zydus Cadila and Sun Pharma — are licensed to manufacture Remdesivir.

Kwality Pharmaceuticals imports Remdesivir API under advanced licence through unregistered sources from China and exports the finished product to 70 countries. But the firm has no legal rights to sell it in India.

MD Ramesh Arora said after CDSCO’s refusal, he has approached Food and Drugs Administration, Punjab, to at least cater to Punjab patients. “I am pained to see the current situation. Many are dying due to Remdesivir shortage, but I am helpless despite having the capacity to meet the demand. If the state government allows, I can instantly meet the demand of the drug in Punjab. The raw material weighing 5-7 kg is lying unused. It can be used to make 65,000-70,000 injections,” he said.

Zonal Drug Licencing Authority official Karun Sachdeva confirmed the acute shortage and irregular supply of the drug. “In Amritsar, 400-500 injections are required daily. Sometimes, we receive over 100 injections, but today we got just 16 injections,” he said.