Indian pharmaceutical industry faces 'a lot of harm' from global scrutiny over cough syrup deaths

India needs to quickly investigate allegations that a local regulator helped switch samples of cough syrups linked to deaths of children in Gambia, and punish the wrongdoers to restore the reputation of the South Asian nation's US$41 billion pharmaceutical industry, analysts have said.

The comments by analysts followed a Tuesday report by Reuters, which reviewed a letter written by a lawyer named Yashpal who accused Haryana state's drug controller, Manmohan Taneja, of accepting a bribe of 50 million rupees (US$605,000) from local manufacturer Maiden Pharmaceuticals to help it switch the syrup samples before an Indian government laboratory tested them. Maiden's factory is based in Haryana state.

Reuters was unable to independently establish that any bribes were paid.

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Indian authorities conducted tests on the Maiden Pharmaceuticals syrups late last year after the World Health Organization (WHO) linked them to the deaths of at least 70 children in Gambia, most below age five, from acute kidney injury between June and October.

Tests of samples of the syrup, which were conducted with help from the WHO, had confirmed the presence of lethal toxins - ethylene glycol and diethylene glycol, commonly used in car brake fluid - and sparked a global hunt for contaminated medicines.

Last month, the Indian government said it would make tests mandatory for cough syrups before they were exported, but analysts said the regulator had to establish stronger quality standards industry-wide.

"This is causing the Indian pharmaceutical industry's brand reputation a lot of harm," said Amir Ullah Khan, a professor of health economics at Dr MCR HRD Institute of Telangana in southern India. "It's not just the manufacturer who should be accountable, but somebody's job has to go."

The government's response of raising standards on exports of cough syrups appeared "knee jerk" rather than comprehensive, Khan said.

Gambia said earlier this month it had hired a US law firm to explore legal action after its own government-backed investigation found contaminated medicines from India were "very likely" to have caused the deaths of children last year, its justice minister said.

Naresh Kumar Goyal, the founder of Maiden Pharmaceuticals, said in December that his company had done nothing wrong in the production of the cough syrup.

In February, an Indian court sentenced Goyal and another Maiden Pharmaceuticals executive to two and a half years in jail for quality violations in drugs sold to Vietnam a decade ago. It gave them a month to appeal.

"If you allow a couple of small companies to destroy the Indian industry's reputation, it will mar those of the big ones as well," Khan said.

However, another industry analyst said it would be unfair to label the entire Indian pharmaceuticals sector as one that makes substandard products.

"India has thousands of pharmaceutical companies including many smaller ones in the informal sector. It will be wrong to conclude that the Indian industry is manufacturing substandard medicines because the case was an exception," said Krishnanath Munde, an associate director at credit rating firm India Ratings.

"It is in everyone's best interest if the importing nation also carries out stringent quality checks," he said.

The South Asian country is the third-largest producer of pharmaceuticals globally, in volume, and manufactures more than half of the world's vaccines. The Indian pharmaceuticals industry has for years been exporting to the United States, Europe, Australia and New Zealand, Munde added.

Satish Reddy, chairman of India-based pharmaceutical firm Dr Reddy's Laboratories, last month told a conference by the Federation of Indian Chambers of Commerce and Industry that the sector hoped to grow to US$65 billion by 2024 and US$130 billion by 2030.

The goals are within reach as long as the sector, which has a vast pool of scientific and technical manpower, ensures high quality standards for all market participants, analysts say.

Some manufacturers might have "cut corners" to maximise profits, said T. Jacob John, a government adviser working on a national project to eliminate measles. But the former chief of virology at Christian Medical College, Vellore in south India cautioned that such people ought to be conscious that "it is India's name that gets spoiled".

"It is not only a matter of the reputation of the pharmaceutical industry, but also a question of life and death," he said, adding that rigorous quality checks needed to be established for every batch of medicine.

"I think these things happen when more than one level is breached. It is very unfortunate, but the children who died, nobody can compensate for them," he said.

This article originally appeared on the South China Morning Post (SCMP).

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