Untested Medicines Flooding Market Could Be Injurious To Health

New Delhi, 5 May 2018: This might come as a bitter pill to swallow. The nonprescription life-saving drugs you are purchasing from the neighbourhood pharmacy could prove fatal.

A communication from the central government to states has warned that several untested and unsafe drugs have flooded the markets that could be injurious to public health.

These medicines have been manufactured and sold in the market without approval of the Drug Controller General of India (DCGI) the central regulatory authority for manufacture and sale of drugs in the country.

A new drug or combination medicine first needs approval by the office of DCGI before it is launched into the market, said Atul Nasa, Delhis drug controller, while quoting the central governments communication. However, it has come to our notice that some states have issued licences for manufacturing and marketing of FDCs (fixed dose combinations) without the approval of DCGI and this has been granted without evaluating the safety and efficacy of drug, which is not in the interest of public health as long term use of FDCs can be harmful to health.

Taking strict note of this, Delhi governments drugs control department has directed all medicine manufacturing units to check the items permitted by it for sale and distribution and any unapproved new drugs including FDCs be immediately reported to the agency.

Fixed dose combinations are life-saving drugs with the mixture of two or more active drugs in a single dosage.

The move has come against the backdrop of recent raids by the state drug controller in Uttarakhand where authorities have found new drugs including FDCs being sold without government approval.

Therefore, we have directed all the manufacturing units to check the items permitted by the department for sale and distribution. Also, they have to inform us regarding the status of new drugs including FDC, if any permitted inadvertently, and immediately inform this office, Nasa said.

These are the directions under section 33(P) of the Drugs and Cosmetics Act, 1940 on cancellation of licences to manufacture drug formulations falling under the purview of new drugs, including FDCs as defined under Rule 122(E) of Drugs and Cosmetics Rules, 1945.

A copy of the government memorandum is with Mail Today which says that a firm is further directed not to undertake manufacture of any such drug without approval and take steps to recall stocks of drugs already sold by it in the market.

Dr YK Gupta, head of the pharmacology department at AIIMS, said, The FDCs are justified when they demonstrate clear rational benefits such as potentiating the therapeutic efficacy, reducing the incidence of adverse effect of drugs, having pharmacokinetic advantage, better compliance by reducing the pill burden, reducing dose of individual drugs, decreasing development of resistance, and cheaper than individual drug because of reduced cost from packaging to distribution. However, today there are a lot of drugs that are of irrational use and are sold by pharma companies just as marketing gimmick.

Pharmacokinetics is a branch of pharmacology dedicated to determining the fate of substances administered to a living being. The substances of interest include pharmaceutical drugs, pesticides, food additives, cosmetics, etc.

Dr Gupta said no state drug controller should give licence for marketing and manufacturing for new drugs and FDCs unless this is cleared by the DCGI.

India Today