New Delhi:As many as 71 drugs and medicines manufactured by different pharmaceutical companies in India have been declared as 'Not of Standard Quality' (NSQ) or spurious by the drug regulator for the month of September.
The substandard and spurious drugs include cough syrup, eye drops, sodium capsules, injection, calcium and vitamin D3 tablets among others.
“As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and a list of spurious drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the spurious drugs list is to make stakeholders aware about the spurious drug batches identified in the market,” drug regulator CDSCO said.
The Central Drugs Standard Control Organization (CDSCO) is the central drug authority for discharging functions assigned to the central government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
Its major functions include regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority among others.
The central laboratories of CDSCO have identified 49 spurious drugs in the month of September.
The drugs that fail to meet the quality standards or specifications are known as “Not of Standard Quality” (NSQ) drugs.
Metronidazole Tablets I.P. 400 mg manufactured by M/s. Hindustan Antibiotics Ltd., At: 11 W.E.A. Faridabad - 121001 (Haryana) R.O. Pimpri, Pune; Domperidon Suspension (Vomitel) manufactured by M/s. Rainbow Life Sciences Pvt. Ltd., C/o. Unijules Life Sciences Ltd., B-35, 36, MIDC Kalmeshwar, Nagpur; Oxytocin Injection I.P. 5 IU/1 ml manufactured by M/s. Pushkar Pharma, Kheri, Kala Amb; Calcium Gluconate Injection I.P. 10 ml manufactured by M/s. Martin & Brown Biosciences Pvt. Ltd., K. No. 918/419, Malkumajra, Nalagarth Road, Baddi, Himachal Pradesh, Calcium 500 mg and Vitamin D3 250 IU Tablets IP manufactured by M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, SIDCUL, Haridwar249403 (U.K), amoing others are some of the drugs found not of standard quality by the central laboratories in September.
Similarly, the state laboratories have found 18 drugs as not of standard quality in the month of September.
Cough syrup manufactured by Kerala Medical Services Corporation Ltd, Thycaud, Thiruvananthapuram has been found as not of standard quality. Laboratory testing of the cough syrup said that the sample fails the ‘Descriptive part’ for oral dosage forms of Schedule V of drugs and cosmetics Act and Rules, as the syrup contains red coloured suspended paticles.
Fluorometholone Eye Drops IP manufactured by Cotec Healthcare pvt.Ltd, K.H.No.593/1, Roorkee, Dehradun Highway, Kishanpur, Roorkee; Wintel 40 Tablets manufactured by Himalaya Meditek pvt.Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun among others have also been declared as not of standard quality.
Several other drugs such as Tamsulosin and Dutasteride Tablets (UrimaxD), Calcium and Vitamin D3 Tablets I.P (SHELCAL 500), Pantoprazole Gastro-Resistant and Domperidone ProlongedRelease Capsules I.P. (PAN-D) and Nandrolone Decanoate Injection IP 25mg/ml (DecaDurabolin 25 Inj.) are also declared as spurious.
“The drugs and medicines found as not of standard quality and spurious are of different batch numbers. Another major reason behind identifying and their declaration is that these specific batch number drugs should be withdrawn from the market,” said a senior government official.
