Strict label standards are in the offing for pharmaceutical products and medical devices. Following this drug makers engaged in contract manufacturing for export purpose would face stringent scrutiny at the customs.
The Drug Controller General of India (DCGI) is in the process of tightening enforcement of export labeling norms, according to official sources. “We are instructing the port authorities to insist that the display of neutral code should be clear and with an English translation of the information, if it is in any other language so that it could be deciphered properly,” an official from the DCGI’s office said. The size of contract manufacturing pharma in India is pegged at about Rs 10,000 crore per annum.
The official said traders and exporters of drugs, who are not the actual manufacturers, cannot use their names under ‘manufacturer’ or ‘manufactured by’. All such cases violate provisions under Drug and Cosmetic Rules and fall under ‘spurious drugs’. After violations of norms, the DCGI had conveyed it to state drug regulators, port and zonal authorities in a letter late last year. The letter, signed by the DCGI Surinder Singh, stated, “...the matter is of serious nature, all concerned are requested to take necessary action in this regard under intimation to this directorate”.
Neutral code is a code given out to a manufacturer by the state licensing authorities that he can use in place of his name and address, which helps locate the coordinates of manufacturer. This provision of neutral code is actually an exemption to the manufacturer under Rule 94 of the Drug and Cosmetic Rules but ensures that information regarding every exported consignment can be traced back to the last detail.
“In many cases, we find that the information on the consignment is written out in a foreign language, in most cases the language of importing country. However, that creates problems for the officials at exit points who bear the responsibility of checking if the standard format of information is being displayed on the consignment. It is logical to ask for the information display in English,” the official said.
The DCGI’s office is taking up the issue with the health ministry. It may also put up a directive related to export labeling norms on its website in near future. Drug exporters engaged in contract manufacturing told that their clients abroad insist on having the label in native languages for regulatory clearances in their countries. “The English translation is not so much of a problem but the government recognizes it only if it is translated by official translators, and that causes delay”, said a Delhi-based drug exporter.
Source: www.drugscontrol.org
0 comments:
Post a Comment