The issues regarding drug safety have dominated public discussion for quite some time including in Jammu and Kashmir. In particular the discussions in the past centered on spurious drugs having harmful side-effects and that it can even kill a person. However, the issue has not hogged headlines or public discussions of late but it does not mean the issue has disappeared or problems associated with it have been perpetually addressed.
Under the Drugs and Cosmetics (Amendment) Act 2008, any drug is deemed to be adulterated or spurious when used by any person for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body.
The Ministry Of Health and Family Welfare informed parliament on March 28 this year that isolated complaints regarding spurious drugs are received in Central Drugs Standard Control Organisation (CDSCO). As and when such complaints are received, based on merit, the matter is taken up by the CDSCO in coordination with the State and UT Drugs Controller for action as per the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945, the ministry said.
The Government, it said, has taken various regulatory measures to ensure the quality of medicines in the country. These include notification for affixing Bar Code or Quick Response Code in Active Pharmaceutical Ingredients (APIs) and some drug formulations, increase in sanctioned regulatory posts of CDSCO and notification providing marketers of any drug to be responsible for its quality. Further, testing capacities of Central Drugs Testing Laboratories under CDSCO have been strengthened, and Drugs and Cosmetics Rules, have been amended.
Also, it said, the Central Government has provided Rs. 665.05 crores for strengthening the drug regulatory system including upgradation of existing State laboratories, setting up of new drug testing laboratories and upgradation of existing State drug control offices as part of “Strengthening of State Drug Regulatory System”.
These steps appear to be good but there must be paraphernalia on ground to ensure that State or UT level drug laboratories are in a position to find quality of drug and also ensure that action is taken whenever drug appears to be spurious, fake etc.
As has been recommended by a Parliamentary Committee, the government must take adequate measures to considerably increase the number of samples of drugs to be tested so as to instill fear in those who indulge in sale and distribution of spurious or non-standard quality drugs. The administration must work seriously. Also the doctors shall also not commit the crime of promoting drugs that can harm the patient.
