Every pharmaceutical manufacturing unit in the country will have to set up patient monitoring cell, in the line of quality cells, with a view to share the onus of patients’ safety by the manufacturers.
The Central Drugs Standard Control Organisation (CDSCO) will issue direction in this regard any time in January to direct the pharma companies to set up the cells. “We are going to observe 2014 as the year of patient and animal safety and creation of monitoring cells will be part of this,” Drugs Controller General of India (DCGI) Dr G N Singh told Pharmabiz.
“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 said.
The move will also aim at creating additional job opportunities in the pharmaceutical sector, especially for the trained pharmacists. The cells would continuously monitor the quality of the products, apart from tracking the adverse reactions of medicines once in the market.
Already on the animal safety front, the government has planned a number of steps including banning of animal testing for cosmetics. The Health Ministry has decided to amend the rules after the issues were raised some Members of the Parliament and activists, and as per the efforts to harmonise the standards in line with the European Union directive in March this year, making the testing of cosmetics on animals completely illegal.
However, the new move to create patient monitoring cells may invite wrath from the industry as it would put additional burden on the companies by way of infrastructure and budget.
Source:Pharmabiz
The Central Drugs Standard Control Organisation (CDSCO) will issue direction in this regard any time in January to direct the pharma companies to set up the cells. “We are going to observe 2014 as the year of patient and animal safety and creation of monitoring cells will be part of this,” Drugs Controller General of India (DCGI) Dr G N Singh told Pharmabiz.
“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 said.
The move will also aim at creating additional job opportunities in the pharmaceutical sector, especially for the trained pharmacists. The cells would continuously monitor the quality of the products, apart from tracking the adverse reactions of medicines once in the market.
Already on the animal safety front, the government has planned a number of steps including banning of animal testing for cosmetics. The Health Ministry has decided to amend the rules after the issues were raised some Members of the Parliament and activists, and as per the efforts to harmonise the standards in line with the European Union directive in March this year, making the testing of cosmetics on animals completely illegal.
However, the new move to create patient monitoring cells may invite wrath from the industry as it would put additional burden on the companies by way of infrastructure and budget.
Source:Pharmabiz
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