Amid mounting pressure and court cases against the ban on 344 drugs, including popular cough syrups Corex and Phensedyl, the health ministry has so far maintained a firm stand saying it will produce all the relevant scientific data and studies to support its decision.Arguing the move is aimed at saving over 20 lakh lives vulnerable to drug resistance in upcoming decades, the ministry said there is no scope for any roll back at present.
“We have deliberated on the issue for a long time and followed a systematic process for more than four years.Companies have also been gi ven a fair chance to present their arguments. We stand firm on our decision and will support it with data in the court,“ a senior official in the health ministry told TOI. He added that the ministry is certainly open to evaluate the move if contrary data is produced by any firm.
Emphasising that the ban on irrational fixed dose combinations (FDCs) was essential to tackle anti-microbial resistance, the official said the government is committed to ensure that only safe products are available in the market.
According to WHO, 53% patients in India use antibiotics without prescription.
Antimicrobial resistance threatens the effective prevention and treatment of an increasing range of infections causing diseases like tuberculosis, malaria, urinary tract infection and even HIV .
India, accounting for the highest number of TB cases, is already the hub of MDR tuberculosis. Of the estimated global annual incidence of 9 million TB cases, India accounts for 2.3 million.
In the absence of an effective pharmacovigilance mechanism to track adverse effects of a drug after it is marketed, the government or drug regulators often fail to track the efficacy and safety of a medicine. Moreover, a highly fragmented pharmaceutical market makes it even more difficult for the regulator to keep a check on many irrational combinations.
“We have deliberated on the issue for a long time and followed a systematic process for more than four years.Companies have also been gi ven a fair chance to present their arguments. We stand firm on our decision and will support it with data in the court,“ a senior official in the health ministry told TOI. He added that the ministry is certainly open to evaluate the move if contrary data is produced by any firm.
Emphasising that the ban on irrational fixed dose combinations (FDCs) was essential to tackle anti-microbial resistance, the official said the government is committed to ensure that only safe products are available in the market.
According to WHO, 53% patients in India use antibiotics without prescription.
Antimicrobial resistance threatens the effective prevention and treatment of an increasing range of infections causing diseases like tuberculosis, malaria, urinary tract infection and even HIV .
India, accounting for the highest number of TB cases, is already the hub of MDR tuberculosis. Of the estimated global annual incidence of 9 million TB cases, India accounts for 2.3 million.
In the absence of an effective pharmacovigilance mechanism to track adverse effects of a drug after it is marketed, the government or drug regulators often fail to track the efficacy and safety of a medicine. Moreover, a highly fragmented pharmaceutical market makes it even more difficult for the regulator to keep a check on many irrational combinations.
SOURCE : Times of India | March 17, 2016
