Foreign drug units face quality check

Foreign drug units face quality check

Ref: Times of India, Mumbai , Tuesday , February 8, 2011 - pg 21

11 Chinese & Two Italian Firms Shortlisted For Inspection

Kounteya Sinha TNN

NewDelhi:Chinese and Italian drug manufacturing units, from where drugs are imported into India in bulk, are now under the scanner. After several import licences of local agents of such overseas units were cancelled due to poor drug quality, the health ministry has given the drug controller general’s (DCGI) office the green signal to send a team of drug inspectors to check foreign units for good manufacturing practices’ (GMP) compliance.

The DCGI’s office has shortlisted 11 Chinese and two Italian drug manufacturing units, which will soon be inspected. A Central Drugs Standard Control Organisation (CDSCO) team will leave for China and Italy soon.

Confirming this to TOI, DCGI Dr Surinder Singh said, “The ministry has given us the go-ahead to inspect foreign manufacturing sites for the first time. A team will leave for China and Italy soon.” A health ministry note, available with TOI, said, “On the basis of complaints and doubts on authenticity of GMP certificate, we cancelled 10 registration certificates and related import licences. All these certificates were from China— from Zhejinag, Jingsu, Henan province and Chongquing.”

Similarly, several cases of imported HIV testing kits originating from Zhejiang and Fujian provinces were declared not to be of standard quality by the government laboratory. “These issues further support this office which stands to carry out foreign site inspections in line with other regulatory agencies of the world,” the note said. According to the rule, once the inspection visit is approved, as has been done in this case by the health ministry, the Indian agent of the shorlisted international company is asked to submit $5,000 within 15 days as a fee. A ministry official said, “Once the fee is submitted, we will leave for inspection.”

So, how did the DCGI select these 13 sites? The DCGI proposes following criteria for inspection of foreign sites. “Drugs which are of critical nature like sterile products, blood products, vaccines and drugs which are consumed vastly like antibiotics, anti-diabetic, antihypertensive drugs, the sites where there is doubt in authenticity or quality of submission are taken as priority,” an official said.

The team will be led by a DCGI official not below the rank of assistant drug controller in position for over two years and who has over five years of experience.

• Govt has cancelled 10 registration certificates and related import licences

• All these certificates were from China

• Several cases of imported HIV testing kits were declared to be of poor quality. Also from China

• An Indian team will leave for China and Italy soon