Celebrating 2014 as ‘Patient and Animal Safety Year’, the Central Drugs Control Organisation (CDSCO) has decided to strengthen the regulatory system to ensure that the drugs imported into the country are checked for their compliance with the existing provisions of the rules and norms.
“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,” a notice by DCGI Dr G N Singh 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.
However, it does not mandate for creation of patient monitoring cells in line with the quality cells in the manufacturing units, as proposed earlier. The DCGI, a few months back, had informed Pharmabiz that the manufacturers would be asked to set up special cells to share the onus of patient safety also for the domestic market.
“We have to fix the onus of patient safety also on the manufacturers. These cells will have dedicated people and they will report to the chief executive officer of the company. We will also make several initiatives as part of the patients’ safety year,” he had told.
The move was also planned to create additional job opportunities in the pharmaceutical sector, especially for the trained pharmacists. The cells were expected to continuously monitor the quality of the products, apart from tracking the adverse reactions of medicines once in the market.