Govt of India starts crack down on low-quality medicine makers

The government of India has started conducting inspections at drug manufacturing units across the country to prevent the production of low-quality drugs and medicines in India.

Typically, inspections are conducted by state authorities, while central agencies largely confine themselves to checking quality of final products put up on store shelves.

However, in the last few years, India has seen the emergence of low quality drug makers.

These drug makers enter into deals with medicine marketing brands to supply drugs at a fraction of the price at which these are sold. Tablets that are sold for Rs 5 each, for example, can be supplied for 20 paise each by these manufacturers.

Many of these drugs have poor or zero potency or efficacy. Though these medicines do not kill or harm patients directly, they contribute to their suffering by lacking the expected efficacy or benefit and can seriously aggravate the disease.

The marketing company in turn ‘ties up’ with doctors to have their (low quality) medicines prescribed.

The doctors, in turn, prescribe the medicines of these unknown brands after being ‘persuaded’ by these agents. The profit from these operations are shared across the eco-system.

Earlier this year, Government of India’s Central Drugs Standard Control Organisation created a checklist for carrying out inspections at drug units.

Subsequently, it identified a number of companies manufacturing drugs in the country for inspections.

A team of five officers each headed by a mid level officer were thereafter deputed to carry out inspections of indentified manufacturing units for a period of three days.

These officers, drawn from CDSCO, Drug Testing Laboratories and State Regulators, were given one week training.

“So far, five rounds of such inspections involving 136 units have been carried out,” the government said.

Despite noticing deficiencies, no action could be taken against the units by the central government as manufacturing of medicines is controlled by the state governments, it added.

“Manufacture of drugs is, in terms of the Drugs & Cosmetics Act, regulated by state licensing authorities and, therefore, action against the manufacturers is required to be taken by the State Licensing Authorities,” it said.

However, said the centre, state authorities have been ‘advised’ to rectify the violations.

The center will conduct follow-up inspections next year to check whether the deficiencies have been fixed or not.

“Further inspections are planned during 2017 to cross check action taken to rectify the deficiencies noticed during inspection,” it added.

India is the world’s largest maker of non-patented medicines, and most of it is exported to markets like the US.

The US Food and Drug Administration conducts regular checks in Indian plants used to manufacture drugs sold in the country. However, checks and enforcement is generally lax in those plants that are used to make drugs for sale in India, especially by contract manufacturers.