Who is responsible for the quality of Indian pharma exports?

The World Health Organization on Wednesday said that deaths of 66 children in the West African country of The Gambia may be linked to contaminated cough and cold syrups made in India, by Delhi-based Maiden Pharmaceuticals.

In a medical product alert covering four India-made paediatric syrups, WHO said laboratory analysis had confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol as contaminants in them, which can be toxic and lead to acute kidney injury.

WHO alleges, all batches of these products should be considered unsafe until they can be analysed by the relevant national regulatory authorities.

The products may have been distributed elsewhere through informal markets, but had so far been identified only in The Gambia, the WHO said in the alert advising regulators to remove these syrups from the market.

The 32-year-old Maiden Pharma, which has two manufacturing plants in Haryana, said it is not selling any product in India currently

Reports indicate India is awaiting more information from the WHO as the UN health agency is yet to provide the exact “one-to-one causal relation of deaths”.

WHO said, information received from India’s Central Drugs Standard Control Organisation indicated that the manufacturer had only supplied the contaminated medications to The Gambia.

The WHO’s Medical Product Alerts are designed to warn member states and public of the existence of dangerous medical products and encourage increased vigilance and appropriate regulatory action.

It has issued five such alerts so far in 2022, 11 in 2021, seven in 2020 and 11 in 2019.

Most of the alerts pertain to falsified medical products that deliberately or fraudulently misrepresent their identity, composition or source.

The deaths of 66 children in Gambia is a blow to India's image as a “pharmacy of the world”.

India is the third-largest producer of medicines by volume and the biggest supplier of generic drugs.

India supplies over 50% of Africa’s requirement for generics, around 40% of generic demand in the US and 25% of all medicine in the UK.

In FY22, Indian drug and pharmaceutical exports stood at $24.6 billion, growing from $22.4 billion in the previous year.

So, who is responsible for quality assurance of pharma exports from India?

Darren Punnen, Leader, Pharma & Life Sciences Practice, Nishith Desai Associates says, for export-only products, manufacturing standards are regulated by India. Product standards not necessarily regulated from Indian law standpoint, he adds. GMP looks at machinery, staff, their competency, and processes.  

The pharmaceutical industry in India is currently valued at $50 billion. The domestic pharmaceutical industry includes a network of 3,000 drug companies and approximately 10,500 manufacturing units.

It also has the highest number of US Food and Drug Administration (or FDA) compliant against pharma factories outside of US.

Consequently, several poor manufacturing practices of the industry came to the forefront, which initially affected many firms adversely but over time led to adoption of better measures which helped the sector to penetrate many markets and achieve global credibility.

Are there any systemic issues plaguing the pharma manufacturing sector that could lead to production of substandard products?

Mahesh Zagade, Former Commissioner, Maharashtra Food and Drug Administration says, diethylene glycol has been found in syrups often. Raw material and finished products are tested for purity, he says. Regulatory oversight lacking in ensuring compliance of these provisions. Supervision by the central government is weak, Zagade says. 

Only after the investigation into The Gambia incident is concluded, will we know where the responsibility lies. If the lapses are found on the part of the manufacturing plant in India, then both the state and central drug regulators could be held responsible. In the meantime, the damage to the Indian pharma industry’s reputation may already have been done.