India’s Drug Regulator Finds 90 Medicines And Drugs Of Spurious And Not Of Standard Quality In October

From July-September, the Central Drugs Standard Control Organisation has detected 195 drugs and medicines as spurious and not of standard quality.

New Delhi:India's drug regulators have detected 90 medicines and drugs that are of spurious qualities and manufactured violating the regulators standard norms in the month of October, the Health Ministry said on Friday.

"As per routine regulatory surveillance activity, the list of Not of Standard Quality (NSQ) and Spurious drugs are being displayed on the Central Drugs Standard Control Organisation (CDSCO) portal on a monthly basis. For the month of October 2024, Central Drugs Laboratories have identified 56 Drug Samples to be not of standard quality (NSQ) and State Drugs Testing Laboratories have identified 34 drugs samples as NSQ,” the Health Ministry said.

Trypsin & Chymotrypsin Tablets (Lysoflam Forte), used to relieve severe pain and swelling in postoperative wounds and other inflammatory conditions has been found not of standard quality. The medicine having the batch number LFTF24002C is manufactured by M/s. Cachet Pharmaceuticals Private Limited of Baddi in Himachal Pradesh. Similarly, an antifungal medication manufactured by M/s. UNITED BIOTECH (P) LIMITED of Baddi in Himachal Pradesh has also been detected as not of standard quality.

Diclofenac Sodium, Paracetamol & Chlorzoxazone Tablets, a medication helps in relieving muscle pain and manufactured by M/s. MODERN LABORATORIES of Indore in Madhya Pradesh has also been found of not of standard quality.

Biocetamol -500, a non-steroidal anti-inflammatory drug used in relieving pain and fever and manufactured by Skymap Pharmaceuticals Pvt. Ltd. of Solan in Himachal Pradesh (HP) is also found as not of standard quality.

Glimepiride Tablets IP 2 mg with batch number LMT240333, used for the treatment of type 2 diabetes mellitus and manufactured by Uttarakhand based Life Max Cancer Laboratories has also been found as not of standard quality.

Stating that such detection is a serious issue, Dr Tamorish Kole, chair of the Clinical Practice Committee of the International Federation for Emergency Medicine said, "Pain Killer and Cough Syrups are common over the counter drugs in India. Hence this is a serious finding and should be dealt with very strictly."

The general public also needs to be cautious and should refrain from rampant use of these medications, he cautioned. "Consult a medical practitioner can save them from any untoward effects of such drugs," he told ETV Bharat.

Identification of drug samples as not of standard quality is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the Government Laboratory and it does not warrant any concerns on the other drug products available in the market, the Health Ministry said.

According to Dr Kole, this is one of the steps to check spurious drugs. "...Others are mandatory bar-coding of medication strips, surprise checks and general awareness," he said.

The ministry said that in October, 3 drug samples picked by the Bihar Drugs Control Authority have been identified as spurious drugs. They have been made by unauthorised and unknown manufacturers, using brand names owned by other companies. Investigation has been initiated in the matter, the ministry said.

“This action of identifying NSQ and spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market," it said.

The CDSCO has found 71 drugs and medicines manufactured by different pharmaceutical companies in India as not of standard quality or spurious in September.

Metronidazole Tablets I.P. 400 mg, a medicine known as antimicrobial agents used to treat bacterial infections of the blood, brain, lung, bone, stomach lining, intestines, gum, teeth, following childbirth or wound infection following an operation was found not of standard quality.

The drugs and medicines found as not of standard quality and spurious are of different batch numbers. Following declaration of such medicines as not of standard quality or spurious, the drug manufacturing companies are bound to withdraw such medicines with specific batch number from the market. From July-September, the CDSCO has detected 195 drugs and medicines found spurious and not of standard quality.