World Health Organization
Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable - so everyone, everywhere can attain the highest level of health.
WHO leads global efforts to expand universal health coverage. We direct and coordinate the world's response to health emergencies. And we promote healthier lives - from pregnancy care through old age. Our Triple Billion targets outline an ambitious plan for the world to achieve good health for all using science based policies and programmes.
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".
Central Drugs Standard Control Organization
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 wam 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.
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.
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. 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.
SYSTEMIC ISSUE
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. However, regulatory oversight lacking in ensuring compliance of these provisions. Supervision by the central government is also weak, he says.
COMPLIANCE SUPER VISION
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.
