Pharma manufacturers oppose bioequivalence tests

Ambika Sharma

Tribune News Service

Solan, May 21

Pharmaceutical investors in the state are opposing bioequivalence tests for existing products which has been made mandatory by the Ministry of Health and Family Welfare through a recent notification.

Terming it as an “undue monetary burden”, the Himachal Drug Manufacturers Association (HDMA) said it would lead to closure of units having a turnover up to Rs 50 crore falling in the Micro, Small and Medium Enterprises category. The association said this would hamper the growth of new pharma units owing to its financial implications and it should be done away with.

They urged that this provision should be made mandatory only for new molecules which were being launched in the country as per the norms laid down by the Drug Controller General of India.

SL Singla, former president, HDMA, said a memorandum opposing this provision was presented to Union Health Minister JP Nadda during his recent visit to Baddi. He said the minister had assured them of looking into the issue.

While elaborating on its financial implications, Singla said a single bioequivalence test costs Rs 10 lakh to Rs 15 lakh and conducting such tests for all products would incur an expenditure of crores on small-scale investors whose trade margins were already shrinking.

He said this proposal was finding opposition from various pharma associations all across the country and representations opposing it had been handed over to the ministry.

The investors based their argument on the recent report of the National Institute of Biologicals survey report which stated that barley 3 per cent of the medicines were found to be not of standard quality and as less as 0.02 per cent drugs surveyed from the market were found to be spurious. This was an affirmation of the fact that drugs marketed in India were of superior quality and the Central government has also vouched for their quality at various international forums.

He said drugs were exported to 220 countries and pharmaceutical units were duly inspected by international inspectors which left little scope for not producing quality drugs.

The state had about 650 pharma units accounted for over 20 per cent of the domestic drug trade and about 20 per cent of the exports.

The investors also opposed the risk-based inspections which were now being conducted jointly by the state and Central drug authorities. Investors claimed that this creates an atmosphere of mistrust and suspicion in the pharma industry.