In order to facilitate import and export of the drugs in the country, Drug Technical Advisory Board (DTAB), apex body on technical matters under the Union health ministry, has agreed for amendment of the Rule 43 A to include Krishnapatnam Sea Port, Nellore and inland container depot Khodiyar, Gandhinagar as port of entry for drugs.
Under Rule 43 A of the Drugs and Cosmetics Rules, 1945, drugs are permitted to be imported from the notified port of entries only. Recommendations were received by the office of the Drug Controller General of India (DCGI) for declaring Krishnapatnam Sea Port, Andhra Pradesh, Vishakhapatnam Sea and Airport, Andhra Pradesh, inland container depot Khodiyar, Gandhinagar and Hazira Port, Gujarat as the port of entry for drugs so as facilitate import and export of drugs from these ports.
Central Government had also allocated Rs. 900 crore for enhancing manpower and capacities of minilabs at port offices and mobile labs at CDSCO level under the 12th five year plan.
Informs an official, "We expect to double the manpower and enhance the lab infrastructure both at the centre and states by the end of 2017. CDSCO has also conducted 17 training programmes to train drug inspectors on carrying out GMP inspections in the year 2013-14 to ensure quality of drugs supplied to over 200 countries from India." Talking about the increasing global requirement for evolving regulatory compliance in regulated and unregulated markets, he stressed on the need for uniformity of GMP inspections for supplying quality drugs globally.
"The practice of deputing drug inspectors as observers through joint inspections has been able to help draw suggestions and feedback from our global regulatory counterparts on continuing good manufacturing practices (GMP). It will help manufacturers in adopting global practices followed in other countries where our medicines are consumed. Similar kind of inspections have also been carried from India to other importing countries for the sake of ensuring quality and consistency. Countries globally are concerned about safe and efficacious medicines to be supplied for the sake of patient safety," he added.