The death of 66 children in Gambia, potentially-linked to four cough and cold syrups made in India by Maiden Pharmaceuticals, has brought up the quality question, again. How did an allegedly contaminated product slip through the regulatory cracks, casting a long shadow on the Indian pharmaceutical industry that has been working to allay quality concerns on medicines that leave Indian shores, be it for North America or Africa?

Cross-country investigations are underway at multiple levels — the World Health Organization (WHO), Gambia and in India (at Central and State levels, since health is a State subject and Maiden is located in Haryana). But pharma industry representatives, most speaking off-record, are emphatic — the buck stops with the manufacturer, they say. “You are in the business of selling medicines, there can be no compromise on QC (quality control),” a seasoned exporter to the African continent told businessline.

But don’t product batches get tested before they are shipped out and don’t importing countries test the product before distributing it locally? It depends on requirements of the importing country, explains Uday Bhaskar, Director General with the Pharmaceuticals Export Promotion Council of India (Pharmexcil). The European Union tests all batches, the United States does random sampling, but Nigeria does pre-shipment quality checks (batches are tested and quality-certified in India before they reach Nigeria), he says, of a method that some industry-insiders seem to be comfortable with.

Sourcing right

Paracetamol syrup is a widely-made product, but it’s also a tricky one to make, says an exporter to countries including Nigeria. It is crucial to ensure that raw material sourced for the product is from quality suppliers. Companies need to have qualified professionals to test raw materials and not take the word of the supplier, who can make a genuine mistake or have malafied intent, he points out.

Early investigations point to contamination with diethylene glycol (DEG) or ethylene glycol, which has been confirmed in some samples following further analysis by WHO.

In fact, the deaths of the children in Gambia, possibly from India-made products became public when the WHO chief Dr Tedros Adhanom Ghebreyesus announced a medical product alert on these syrups. The WHO had informed the Drug Controller General of India (DGCI) on September 29. And the Indian regulators have since picked up control samples from the company for further testing. These reports will be crucial in revealing the source of DEG in the product.

Key pharma industry associations have distanced themselves from the company in the dock and industry-insiders are calling for a quick and speedy action, as such a development has ramifications on the industry. Meanwhile, Maiden Pharma has said in a statement to ANI, that they were following Central and State regulatory protocols and that they sourced raw materials from reputed companies.

Multiple standards

For years now, the concern on quality has Central regulatory officials pointing to manufacturing licences supplied by State regulatory authorities, the suggestion being that some States were more pliant than others when it comes to approving products, not of standard quality.

The challenges are two-fold, says Ranjit Shahani, President Emeritus, Organisation of Pharmaceutical Producers of India (OPPI), a platform largely for multinational companies. “There are 3,000 companies across the country and some of them are mere hole-in-the-wall outfits. For that size, do they have the scale and manufacturing that follows current Good Manufacturing Practices (cGMP)? They all need to be regulated and for that regulatory resources need to be increased, so action taken is speedy, effective and perpetual, says Shahani, former Vice-Chairman, Novartis India.

Nigeria experience

Former Joint Commissioner and controlling authority with the Maharashtra Food Administration, Ramakant Gudal, says DEG is toxic and should not be used, and the propylene glycol used as a solvent should be pharmaceutical-grade. Gudal’s QCS Labs LLP is involved with pre-shipment checks done on exports to Nigeria. These check have helped in sending products with clean report of inspection and analysis, he says.

Key facts at a glance
The contaminated syrups: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup 
According to Pharmexcil, India’s pharma exports to Africa stood at $3.83 billion in FY22, out of total exports of $24.6 billion. It is $1.87 billion in April to September of FY23
Africa accounts for 15.66% of total pharma exports. About 45% of Africa’s generics market valued at $8 billion is from India

QCS’ Dr Asha Gudal adds, pre-shipment checks in India are done by labs appointed by NAFDAC (the Nigerian health authority). Local inspectors are sent to the exporters’ facilities, documents checked and samples are randomly tested, she said, before the consignment is made tamper-proof and sent. Samples that are not tested are labelled, so the Nigerian authorities have all the data and can test at their end as well.

Pharmexcil’s Bhaskar says a track-and-trace system is also in place for secondary and tertiary packaging on exported products to take quick action, if there’s a problem. “This case is an aberration”, he says, but Indian authorities will need to investigate and take quick action, in the interest of keeping the faith in medicine exports from India. Presently, 55 per cent of pharma exports go to the regulated markets, he added.

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