Central drug regulator now raids pharmacies

Takes over role played by state agencies so far, seizes banned medicines

For the first time in its history, the apex drug regulator Central Drugs Standard Control Organisation (CDSCO) bypassed the state drug regulators to conduct surprise raids to seize banned drugs from chemist shops and hospital pharmacies in two states.

Of the 134 retail medicine outlets covered during the raids conducted in Delhi and Bhiwadi in Rajasthan on June 15, the agency traced presence of banned drugs in 85 shops, indicating prevalence of a poor drug recall system across the country.

It also raised questions over the effectiveness of the various state drug regulatory departments, which have traditionally been monitoring the implementation of national-level decisions taken by the central agency.

While the central regulator’s role has always been in giving marketing approvals, permission for retail sales and licenses for retail outlets used to be handled by the state-level drug regulating agencies. However, the Drugs and Cosmetics Act, 1940, under which both agencies function, does not differentiate between state and central drug inspectors when it comes to powers to raid or seize medicines.

While the bulk of the shops raided during the first three hours of CDSCO operation showed presence of banned products, the subsequent searches carried out by the state drug regulators across the nation in the following days did not yield much result, senior officials said. CDSCO chief, or the Drugs Controller General of India (DCGI), had instructed all state drug authorities to conduct similar searches for banned drugs in drug retail outlets across the country.

“There were 13 teams comprising of 56 officials that participated in the raids. Each team was headed by an assistant drugs controller (India) with drug inspectors and other staff from CDSCO headquarters in Delhi,” DCGI Surinder Singh said.

“We have issued orders not to dispose of the stocks of prohibited drugs. The stocks will be seized according to the rules,” he added.

The banned drugs commonly traced in the Delhi and Rajasthan raids were anti-diabetic drug Rosiglitazone (banned in November 2010), antibiotic Gatifloxacin and irritable bowel syndrome drug Tegaserod (both banned in March 2011). CDSCO wanted these drugs to be recalled from the distribution channels as these posed health risks to the patients and there were better alternatives available.

The medicine brands of most leading pharmaceutical companies such as Cipla, Dr Reddys, Sun Pharma, Lupin, etc, were among the ones found, officials said.

When contacted, industry representatives said the company had indeed stopped the production from the date of ban and had instructed the distribution channels to withdraw the batches that were already in circulation.

Retail chemists said they were not aware of CDSCO’s powers to inspect their shops as they have always been interacting with state drug inspectors in charge of their area. Senior health ministry officials said the fault was with the retail outlets and the authorities are exploring the legal options available.

Under the law, stocking prohibited drugs is a non-bailable offence that can attract a jail term of up to two years and a fine of Rs 5,000. CDSCO officials said such raids would be more frequent in future.