INDIAN PHARMA SECTOR

Indian pharmaceutical companies are coming under increased scrutiny overseas due to repeated incidents of deaths and disabilities because of poor quality of drugs. This increased distrust on Indian drugs compelled Union Health Minister Mansukh Mandaviya to announce that 71 companies have been issued show-cause notices following reports about deaths due to contaminated cough syrups made in the country, and 18 of them have been asked to shut shop. Incidents around the globe involving Indian medicines leading to death/ serious ailment of patients are summarized below to put the Minister’s statement in perspective: –

Gambia – Cough Syrup

From June to November 2022, 82 children were confirmed to have suffered acute kidney injury, out of these 70 died. WHO issued an alert stating that the 4 x cough syrups being supplied to Gambia by India Haryana based Maiden Pharmaceuticals Ltd were of substandard quality and contained unacceptable amounts of two contaminants. A joint probe by Centres for Disease Control and Prevention (CDC) of US and Gambian health authorities suggested a strong link between death of Gambian children and consumption of made in India cough syrups.

Uzbekistan – Cough Syrup

In Dec 22, 18 x children died in Uzbekistan due to consumption of cough syrup ‘Dok1 Max’ manufactured by Noida based firm Marion Biotech. Accordingly, WHO issued a warning against the use of 2 x Indian made cough syrups Ambronol and DOK-1 Max and said that laboratory analysis of these 2 x syrups samples found unacceptable amount of diethylene glycol and / or ethylene glycol as contaminants. Both are toxic to human, especially children and may result in death.

USA – Eye Drops

Centre for Disease Control and Prevention (CDC), the top medical watchdog in US linked Indian eye drops to 81 drug-resistant bacterial infections, four deaths and 14 cases of vision loss including four involving removal of eye ball. Global Pharma Healthcare, a firm based in Tamil Nadu’s Chennai was the manufacturer of the eye drops sold under brand named EzriCare Artificial Tears. It recalled eye drops and ointment exported to the US in February 2022.

Marshal Islands – Cough Syrup.

In April 23, WHO flagged an Indian made cough syrup Guaifenesin in the Federal States of Micronesia and Marshall Islands for containing impermissible amounts of ethylene and diethylene glycol. The contamination was identified by the Australian regulator.

Sri Lanka- Eye Drops

In April 2023, 30 x people were affected in Sri Lanka while using methylprednisolone eye drops manufactured by Gujarat based Indiana Ophthalmics. The eye drop was found to contain bacteria Burkholderia cepacia. (2) Sri Lankan government asked Indian government to look into the matter and Indian Central Drugs Standard Control Organisation (CDSCO) is investigation the matter.

Nigeria – Cough Syrup & Paracetamol

Nigeria’s NAFDAC declared two Indian drugs, a cough syrup and an oral Paracetamol substandard and toxic on 12 Jun, flagging drug makers from Punjab (QP Pharmachem) and Mumbai (SyneCare).

Sri Lanka – Anaesthetic

On 16 June, a patient undergoing treatment at the Peradeniya Teaching Hospital in the Knady district died after being given the Indian-manufactured anesthetic Bupivacaine. Reaction of Indian authorities and regulator was denial of any wrong doing by the drug manufacturing companies to the extent that even Indian press was compelled to remind the authorities that watchdog was not a facilitator for the pharma industry and its job was to ensure drug safety. The deceptiveness of Indian claims was made clear by Bloomberg report which made public the damning details of the state of Indian pharma factories as revealed during FDA inspections and obtained under the Freedom of Information Act (FOIA). The issue has however failed to cause the sort of reputational damage expected from deaths of children, serious infections in a country like USA and blatant lying by Indian regulators. This is because of alignment of Western interests with India to contain China and more importantly lack of any concerted media campaign against India.