India pharma firms caught for exporting counterfeit drugs

Two Indian pharmaceutical companies have been charged under the country's Drugs and Cosmetics Act for exporting counterfeit diabetes drugs.

India's Food and Drug Administration (FDA) investigated Pharmaceutical Products of India Ltd and Wanbury and found the firms had a manufacturing and export deal where they were illegally rebranding and exporting the diabetic drug metformin hydrochloride to Bangladesh, Brazil, Mexico and Pakistan.

The investigation, based on a tipoff, found that Wanbury had an export licence and orders of 650 metric tonnes per month for the drug but had a shortfall of around 300 metric tonnes in manufacturing capacity. To meet the demand, Pharmaceutical Products of India, which did not have an export licence, would manufacture the shortfall and sell to Wanbury.

On receiving the product from Pharmaceutical Products of India, Wanbury would re-label as Wanbury drugs without any quality checks and then export to the clients. The illegal activity had been going on for several years.

During the investigation, the FDA vigilance team found and seized Rs 47 lakh worth of drugs ready for export to Mexico. The companies were believed to be exporting almost $1m worth of the drug each month.

"Pharmaceutical Products of India (PPIL) had not even applied for an export licence, and the Drugs and Cosmetics Act treats metformin hydrochloride exported by PPIL as spurious, as any drug has to be subjected to quality control standards before it can be exported," an FDA official said. "Such unholy alliances can have disastrous effects on the country's drug export sector."

This is the second counterfeit incident in recent months. In August the FDA investigated two other Indian pharmaceutical companies for rebranding and exporting drugs that had been manufactured by another company.

In early October, Dr Jayesh Lele, president of the Indian Medical Association, called for a "multipronged approach" to "rein in" the counterfeit drug problem facing India.

The high price of drugs, poverty, poor supply chain, ineffective regulations and enforcement were the major factors for the spread of counterfeit drugs, he said, suggesting that proper regulation and monitoring, legislation, strict enforcement, supply chain management, technical innovations, vigilance and international cooperation were some of the measures that needed to be adopted.

Prior studies - which have been disputed - suggest that just 0.4 per cent of drugs produced in India are fake, with one in seven are of substandard quality. The country exports around 35,000 crore ($5.2bn) worth of drugs per year.