India to join global scheme to improve quality of drugs

The move to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) was triggered by the deaths of 66 children in Gambia that were linked to toxic Indian-made cough syrups (AFP)
The move to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) was triggered by the deaths of 66 children in Gambia that were linked to toxic Indian-made cough syrups (AFP)

Summary

As per a London School of Economics research, the UAE uses reference prices from relatively developed markets which observe high standards for medical products. They include Austria, Bahrain, Belgium, Canada, France, Germany, Italy, Switzerland and the UK.

New Delhi: India is set to join an international regime that fosters cooperation between countries and regulatory authorities in good manufacturing practices (GMP) in order to improve the quality of their medical products, a government official aware of the development said.

The move to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) was triggered by the deaths of 66 children in Gambia that were linked to toxic Indian-made cough syrups. A second factor was market access problems faced by Indian medical products in quality-conscious UAE and Gulf Cooperation Council.

“We will have to prepare the Indian industry, especially micro, small and medium enterprise, for PIC/S that would entail adopting global standards by adopting good manufacturing practices. The decision will not only help avert Gambia-like tragedies, but also help gain market access in advanced markets," the official quoted above stated.

The official said the UAE and GCC and several other advanced economies use mechanisms that reference prices in developed markets to fix their own prices. But such mechanisms act as a barrier for affordable Indian drugs even though, the official said, they are of superior quality.

“Joining PIC/S will solve the problem of market barriers as India will be among the countries whose prices will also be used for referencing," the official stated.

Mint had earlier reported that India is holding high-level talks with the UAE to find a solution to pricing norms in the Gulf nation that act as a barrier to Indian generic drug and vaccine exports. As per a London School of Economics research, the UAE uses reference prices from relatively developed markets which observe high standards for medical products. They include Austria, Bahrain, Belgium, Canada, France, Germany, Italy, Switzerland and the UK.

Experts said the absence of India and China where prices are low means that the price mechanism is tilted on the higher side and therefore acts as a barrier for Indian exporters of affordable medicines. “PIC/S was established to harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries. PIC/S is also a body that harmonizes relations among regulatory authorities and governments," India’s pharma export promotion body Pharmexcil said.

Pharmexcil said the role of PIC/S is to thoroughly assess the regulatory process of a drug regulatory authority in a country and make necessary changes if necessary in the protocols of manufacturing and quality control so as to harmonize good manufacturing practices among the member countries.

The US, UK, Switzerland, Japan, Germany and France, among several high-value pharma markets, are members of PIC/S. Earlier this month, Reuters reported that Gambia has hired a US law firm to explore legal action after a government-backed investigation found that contaminated medicines from India were likely to have caused the deaths of children last year.

Concerns around Indian pharma exports to African countries aren’t new. Much before the Gambia tragedy last year, researchers had warned that Indian drug makers cut corners and make substandard drugs for markets with non-existent or under-developed regulatory oversight such as in Africa.

Queries sent to the Union health ministry and the ministry of commerce remained unanswered till press time. Two executives of Maiden Pharma— the company whose cough syrup is linked to the Gambia tragedy— have been sentenced to two-and-half years in jail in a nine-year-old case relating to shipments of substandard drugs to Vietnam.

In a 2014 Nation Bureau of Economic Research (NBER) paper report titled ‘Poor Quality Drug And Global Trade’, researchers said that 10.9% of the 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa were substandard and failed a basic assessment of active pharmaceutical ingredients (API).

In February this year, two company executives of Maiden Pharma, the company allegedly responsible for the exporting contaminated medicines to Gambia were sentenced to two years and six months in a decade old case of substandard drugs to Vietnam.

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