On government direction on Indian drug standards: A partial remedy

Source: The post is based on the article “Express View on government direction on Indian drug standards: A partial remedy” published in “The Indian express” on 7th August 2023.

Syllabus: Issues relating to development and management of Social Sector/Services relating to Health.

News: A much-needed action was taken last week when the government issued a directive requesting that drug producers adhere to WHO guidelines.

What are the recent incidents that have dented the country’s reputation as a reliable source of inexpensive generics?

In October 2022, over 60 children in Gambia died due to kidney complications from cough syrups made by Haryana-based Maiden Pharmaceuticals.

Within three months, another cold remedy by Marion Biotech in Noida was blamed for 19 children’s deaths in Uzbekistan.

In March 2023, Cameroon authorities associated a batch of cough medicines from an Indore-based firm with at least 12 fatalities.

The World Health Organization found toxic content in seven Indian-made cough syrups.

Surveys by Indian authorities have also revealed serious shortcomings in at least 160 pharma units.

What are the reasons for such incidents?

Lack of WHO certification: Less than 20% of Indian pharma units are WHO-certified, indicating poor quality control.

Outsourcing to MSMEs: Large companies often outsource production to small and medium-sized enterprises where quality might be compromised for cost reduction.

Inadequate regulatory staffing: For instance, Haryana’s drug monitoring department had less than 40% of its required staff during the Maiden Pharma case investigation.

Misallocation of inspectors’ duties: Inspectors often handle administrative work related to licenses, causing a neglect in drug safety and efficacy checks.

Limited testing facilities: India only has 31 government-run drug testing labs, which is not sufficient.

Lack of transparency and public information: There is limited information about inspection procedures and violations that could warn regulatory authorities, doctors, and healthcare institutions.

What should be done?

Implement WHO standards: The government should require all pharmaceutical manufacturers to adhere to these global norms.

Improve regulatory oversight: This includes hiring more staff for drug monitoring and focusing their work on drug safety checks.

Enhance testing facilities: Increase the number of state and central drug testing laboratories.

Create a violation database: This would alert authorities, healthcare institutions, and doctors about inspections and violations.

Increase transparency: Publicly share information about procedures followed during investigations and manufacturing standards.