The Central Drugs Standard Control Organisation (CDSCO) has given three months more for the companies to comply with the relabelling norms for imported drugs, after the industry expressed concerns on the enhanced rules and tightened norms.
“In the light of various representations received from OPPI, FICCI, CII, IDMA and other stakeholders on relabelling issue of imported drugs, a special meeting with the stakeholders was held on direction of the Ministry of Health and Family Welfare on March 26,” said a notice from the Drug Controller General of India (DCGI) Dr G N Singh.
As Port Offices have started the meticulous implementation of labelling requirements, the importing organisations have expressed their inability to change as per Drugs and Cosmetics rule to India specific labelling in short span of time and approached the DCGI to allow some time for transition from universal to India specific labelling so that supplies of drugs to the patients are not hampered, as per the notice.
“Accordingly, it has been decided in the interest of patients safety and well being, that those drugs which are imported under universal packing and needs relabelling post import, in order to comply with Drugs and Cosmetics rules, are given general permission under rule 104-A for three months in cases of drugs and six months for devices and cosmetics under Drugs and Cosmetics At and Rules,” the DCGI said.
Recently, the DCGI had issued a notice saying that the CDSO would celebrate 2014 as patient & animal safety year. “The CDSCO is celebrating the year 2014 as Patient and Animal Safety year. In its endeavour to ensure the mission of CDCO to safeguard and enhance the public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices in letter and spirit, it has been decided that the drug products which are being imported in the country be checked for their compliance with the provisions of the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules, 1945,” the earlier notice said.
“As the patient’s safety is of paramount importance, it has been decided that the drugs for import into the country shall be allowed only if they are in compliance with the requirements of the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945,” it added.