The Department of Pharmaceuticals is likely to approve the suggestion of sending a technical officials delegation for on-site inspection of the facilities in China supplying pharmaceutical ingredients to India, with a view to ensure quality of the products being imported.
The Department is learnt to have agreed to discuss the matter with the Drug Controller General of India (DCGI) office and take necessary steps in this regard, as repeatedly demanded by the industry, especially the bulk drug manufacturers who heavily depended on China for import of raw materials and ingredients. The industry leaders who met senior officials of the department at a recent meet in Hyderabad also reiterated the demand to send a combined delegation of the technical officials of the chemicals ministry and the DCGI office.
DCGI Dr Surinder Singh sometime back had backed the idea mooted by the industry. He said that he was willing to spare the qualified people and fund, provided that required permission was granted to go ahead.
"We have the right to inspect all the facilities from where the bulk drugs or ingredients coming, whether it is China or some other country. While the developed world insist on the latest regulatory norms in our industry and manufacturing units, we also have the right to check whether they themselves adhere to such norms before importing raw materials to our country," an industry leader said.
As part of making the import norms more stringent, the industry also urged the government to raise the existing fee structure heavily. The bulk drug registration fee should be hiked to at least 20,000 dollar from 2000 dollar and registration be given only after sufficient inspections, the industry had demanded.