Amid controversy surrounding India-made drugs that allegedly caused the deaths of children in the Gambia, the Central Drugs Standard Control Organisation (CDSCO) has started conducting inspections of identified drug manufacturing units jointly with state authorities across India.
The idea of the joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country, the Union ministry of health said.
However, this is not the first time such widespread joint inspections have happened in India.
Speaking to Business Standard, Navneet Marwaha, state drug controller of Himachal Pradesh, said similar joint inspections were conducted in 2016 as well.
"In 2016, facilities across several states were covered to check the quality of drugs. In-depth studies were done. The Drugs and Cosmetics Act has provisions for risk-based inspections, and are done from time to time," said Marwaha.
These inspections are usually carried out simultaneously across the country, Marwaha added.
In 2016, it had taken around two to three months to complete the inspections of the identified facilities.
Industry sources estimate that India has 10,500 drug manufacturing facilities.
Most of these are concentrated in the manufacturing hubs of HP, Sikkim, Gujarat, Maharashtra, and Andhra Pradesh. HP, for instance, has 642 units and 40 state drug inspectors.
"Each state has deputed central drug inspectors. Conducting joint inspections will not be a problem of manpower," claimed Marwaha.
Currently, joint inspections are being conducted all over the country in line with standard operating procedures on Union Health Minister Mansukh Mandaviya's directions.
An action plan for the nationwide inspection of manufacturing units identified to be at risk of manufacturing adulterated/spurious drugs was made prior to the inspections, according to the statement.
A committee of two joint drug controllers has been constituted at the CDSCO headquarters to monitor the process of inspection, reporting, and subsequent action to ensure compliance with the Drugs and Cosmetics Act, 1940, and Rules, 1945, the statement said.
This will ensure high standards of quality compliance with respect to drugs made in the country, it said.
'The drug control administration is required to ensure that manufacturing units comply with the Drugs and Cosmetics Act, 1940, and Rules thereunder especially to the requirements of good manufacturing practices,' the health ministry statement said.
However, industry sources indicate that India does have a problem of manpower at the state and central drug regulatory offices.
According to the R A Mashelkar Committee, which made recommendations for improved drug regulation, there ought to be one drug inspector for every 50 manufacturing units and one per 200 distribution retailers.
An IndiaSpend report of 2019 pointed out that many sanctioned posts of drug inspectors remained vacant in states.
For example, Karnataka had 53 per cent vacant seats, HP 27 per cent vacant seats, and Tripura 26 per cent vacant seats.
Meanwhile, the issue of cough syrups manufactured by India's Maiden Pharmaceuticals (Maiden Pharma) allegedly leading to the deaths of 70 children in Gambia has been in the news of late.
A parliamentary committee in Gambia has recommended the prosecution of an Indian manufacturer of cough syrups suspected of causing the deaths of at least 70 children in the West African country.
This was in contrast to what the Indian regulator had found in its inspection of cough syrup samples from Maiden Pharma's Sonipat plant.
Drugs Controller General of India V G Somani had written a letter to the World Health Organisation, saying samples of Maiden Pharma's four cough syrups under scanner that were sent to government laboratories for testing have been found to be 'complying with specifications'.
Indian authorities, however, did not decide to reopen the Maiden Pharma plant, saying that the shutdown was ordered due to violations in good manufacturing practices.
The Haryana state regulator had said a joint team comprising inspectors from the state Food and Drug Administration and CDSCO would visit the plant for a re-inspection before it is allowed to be reopened.
