India drugs regulator orders quality checks on cough syrup ingredient

People wait for their turn to buy medicine outside a pharmacy in Amritsar, India on March 28, 2020. (AFP/File)
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Updated 09 December 2023
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India drugs regulator orders quality checks on cough syrup ingredient

  • Syrups made by three Indian firms have been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon in over a year 
  • Drugmakers have denied allegations their products were responsible for the deaths, which have cast a shadow over quality of Indian exports 

NEW DELHI: India’s drugs regulator has ordered that the source and quality of an ingredient used to make cough syrups be checked and verified as a “top priority,” in the wake of the deaths of at least 141 children globally. 

In one of the world’s worst such waves of poisoning, cough syrups made by three Indian manufacturers have been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since the middle of last year. 

The drugmakers have denied allegations that their products were responsible for the deaths, which have cast a shadow over the quality of exports from India, often dubbed the “world’s pharmacy” due to its supply of life-saving drugs at low prices. 

In a letter this week, India’s Drug Controller General Rajeev Singh Raghuvanshi directed state and regional authorities to carry out inspections and verify the source and quality of propylene glycol (PG) either produced domestically or imported by cough syrup makers. 

He also directed drugs inspectors to submit a supply chain verification report for PG manufacturers and importers 

The direction was issued to rule out “possible quality issues” related to toxins diethylene glycol (DEG) and ethylene glycol (EG) in cough syrups and the diversion of industrial grade PG, Raghuvanshi said in a letter dated Dec. 6 and seen by Reuters. 

PG is a colorless, viscous liquid that does not react with other substances, making it an ideal solvent for syrupy medicines. Reuters has reported that some Indian drugmakers were buying key ingredients from suppliers who were not licensed to sell pharmaceutical-grade products. 

DEG and EG are used as industrial solvents and antifreeze agents and can be fatal when consumed even in small amounts. 

The syrups linked to the deaths of the children were found to contain high levels of DEG or EG in tests done by the World Health Organization and other authorities. 

Raghuvanshi has requested details including the number of cough syrup batches manufactured across India in 2023, the PG used and whether it was tested before use. 

Raghuvanshi also issued an advisory on Dec. 5 asking all drugmakers to purchase and use only pharmaceutical grade ingredients in their products. 

India has introduced mandatory testing for cough syrup exports since June and stepped up scrutiny of drugmakers, finding a string of deficiencies in recent inspections including poor documentation and a lack of self-assessment. 


New ‘superfood’ transforms livelihoods in India’s rural east

A farmer harvests makhana, or lotus seeds, in Kapchhahi village in India’s eastern state of Bihar. (Mahesh Mukhia)
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New ‘superfood’ transforms livelihoods in India’s rural east

  • Known as fox nut or lotus seed, makhana is rich in protein, dietary fiber, minerals
  • Most of the world’s makhana production is in Bihar, one of India’s poorest states

BIHAR: Wading through knee-deep, stagnant water, Mahesh Mukhia plunges his hands into the mud, pulling up handfuls of sludge that he and others toss into a large, partially submerged basket.

After a while, they shake the basket to drain away the water and debris. What remains is makhana — round black seeds that have lately gained popularity as India’s new superfood.

A regional Indian snack, also known as fox nut or lotus seed, makhana is the edible seed of the prickly waterlily. The plant grows in freshwater ponds and wetlands in southern and eastern Asia.

After makhana seeds are handpicked from pond beds, cleaned, and sun-dried, they are roasted at high heat so their hard black shells crack open and release the white, popcorn-like puffed kernels, which are eaten as snacks or used in dishes.

It has long been known for its nutritional value — high in plant-based protein and dietary fiber, the seeds are also rich in minerals and gluten-free — which over the past few years have helped it gain global attention and are transforming farmlands in Bihar, one of India’s poorest states.

“Earlier, people were not researching it but now, after research, makhana’s nutritional values have been highlighted. Now this is a superfood. That’s why demand is growing everywhere,” said Mahesh Mukhia, a farmer in Kapchhahi village in Bihar’s Darbhanga district, whose family has been harvesting the seeds for generations.

“The difference is that my forefathers did farming in a traditional way, but we’ve learnt to do it in a scientific way,” Mukhia told Arab News.

“There is Bhola Paswan Shastri Agricultural College in the neighboring Purnea district. I went there for training. After I started practicing farming the way I learnt, the yield increased by more than 30 percent.”

Makhana farming is highly labor-intensive, starting with the cultivation of water lilies in shallow ponds. The plants require constant monitoring as they are sensitive to water levels and pests.

Harvesting takes place between August and October. Workers pluck the seeds by hand and then dry them under the sun for several days before they can be processed.

The processing and roasting of makhana also require significant effort. The dried seeds are first de-shelled by manually cracking them, followed by multiple rounds of roasting to make them crisp.

Whole families are involved in the production, which has been expanding since 2020, when the state government introduced the Makhana Development Scheme.

Besides training in farming and processing, growers who cultivate fox nut receive $820 per hectare.

“The rate has also gone up. The makhana that we used to sell at 200-300 ($2-$3) rupees per kg is now selling at 1,000 ($12) or 1,500 rupees per kg,” Mukhia said.

“Makhana farmers are now making a profit. Those who are growing makhana are earning well, those who are popping it are also doing well, and those involved in trading are making profits too. We are getting good demand from everywhere. I just received an order for 25 tonnes recently.”

Bihar currently produces over 85 percent of India’s makhana and accounts for most of the world’s production, according to Ministry of Commerce and Industry estimates.

According to reports by the Indian Brand Equity Foundation and the Agricultural and Processed Food Products Export Development Authority, India accounts for roughly 85 to 90 percent of the world’s production.

Farmland where the crop is grown has increased many times over the past decade and can now be compared to the area covering half of New York City.

More than 600,000 people are involved in the makhana industry in Bihar, according to Niraj Kumar Jha, Darbhanga district’s horticulture officer.

“Earlier, we were cultivating 5,000 hectares in the Kosi and Mithlanchal regions. But now it has expanded to 35,000 hectares, and with many supportive schemes, farmers are increasingly encouraged to grow makhana,” he said.

“We are strengthening our marketing channels. We’ll reach the metro cities as well as world markets ... We can see that makhana is growing very popular, not only in India.”