The Central Drugs Standard Control Organization responsible for regulating the quality of drugs and cosmetics in India recently found 40 drugs and injections manufactured in 25 pharmaceutical industries in Himachal Pradesh to be substandard. CDSCO conducts regular inspections of pharmaceutical industries to ensure that the drugs they produce meet the required quality standards. The drugs were found to contain lower levels of active ingredients than they were supposed to, or they contained impurities that could be harmful to consumers. The drugs that were found to be substandard included drugs for a variety of common medical conditions, such as asthma, fever, diabetes, hypertension, allergies, epilepsy, cough, antibiotics, bronchitis, and gastric. In addition, multi-vitamins including calcium supplements were also found to be substandard.
The CDSCO has taken action against the pharmaceutical industries that produced the substandard drugs. The industries have been ordered to recall the affected drugs from the market and to take steps to ensure that the quality of their products meets the required standards. In fact, in the month of December, the CDSEO (Central Drug Standard Control Organization) issued a Drug Alert on the entire issue. Moreover, samples from 38 different drugs manufactured in pharmaceutical industries in Uttarakhand, Punjab, Gujarat, Andhra Pradesh, Uttar Pradesh, Mumbai, Telangana, and Delhi have also failed during inspections. Eight samples of Heparin Sodium injection, used in the treatment of blood clots and manufactured by Alliance Biotech in Baddi, failed from various batches. Similarly, five samples of Vitamin D3 tablets manufactured by Kanha Biotechnic in Jharmajri have also not met the required standards. Among the 25 pharmaceutical companies included in the drug alert, several companies have had repeated failures in the inspection of their drug samples. It is noteworthy that there is an ongoing trend of drug samples failing in the state. According to the Drug Alert issued by CDSEO, over 50% of the declared substandard drugs are manufactured in pharmaceutical companies in Himachal Pradesh.
In December, the Central Drugs Standard Control Organization collected samples of 1008 drugs from different states across the country, out of which 78 drugs were found to be substandard during the inspection, while 930 drugs met the required quality standards. These drug samples were collected from Himachal Pradesh, Odisha, Arunachal Pradesh, Meghalaya, CDSEO Baddi, Rishikesh, Ghaziabad, Bengaluru, Kolkata, Chennai, Mumbai, Ghaziabad, Ahmedabad, Hyderabad, and the Drug Department for inspection. The testing was conducted in the CDL (Central Drug Laboratory) and the inspection report was made public on Tuesday. Deputy Drug Controller Manish Kapoor has informed that notices have been issued to all the relevant pharmaceutical companies included in the Drug Alert, instructing them to provide reasons. Furthermore, directives have been given to recall the entire stock of the respective batches. Additionally, strict actions are being taken against those industries whose samples are repeatedly failing. Both units of Kanha Biotechnics have been shut down now, a month after the order to cease manufacturing.
List of drugs mentioned in the December drug alert
The Central Drugs Standard Control Organization responsible for regulating the quality of drugs and cosmetics in India recently found 40 drugs and injections manufactured in 25 pharmaceutical industries in Himachal Pradesh to be substandard. CDSCO conducts regular inspections of pharmaceutical industries to ensure that the drugs they produce meet the required quality standards. The drugs were found to contain lower levels of active ingredients than they were supposed to, or they contained impurities that could be harmful to consumers. The drugs that were found to be substandard included drugs for a variety of common medical conditions, such as asthma, fever, diabetes, hypertension, allergies, epilepsy, cough, antibiotics, bronchitis, and gastric. In addition, multi-vitamins including calcium supplements were also found to be substandard.The CDSCO has taken action against the pharmaceutical industries that produced the substandard drugs. The industries have been ordered to recall the affected drugs from the market and to take steps to ensure that the quality of their products meets the required standards. In fact, in the month of December, the CDSEO (Central Drug Standard Control Organization) issued a Drug Alert on the entire issue. Moreover, samples from 38 different drugs manufactured in pharmaceutical industries in Uttarakhand, Punjab, Gujarat, Andhra Pradesh, Uttar Pradesh, Mumbai, Telangana, and Delhi have also failed during inspections. Eight samples of Heparin Sodium injection, used in the treatment of blood clots and manufactured by Alliance Biotech in Baddi, failed from various batches. Similarly, five samples of Vitamin D3 tablets manufactured by Kanha Biotechnic in Jharmajri have also not met the required standards. Among the 25 pharmaceutical companies included in the drug alert, several companies have had repeated failures in the inspection of their drug samples. It is noteworthy that there is an ongoing trend of drug samples failing in the state.According to the Drug Alert issued by CDSEO, over 50% of the declared substandard drugs are manufactured in pharmaceutical companies in Himachal Pradesh. In December, the Central Drugs Standard Control Organization collected samples of 1008 drugs from different states across the country, out of which 78 drugs were found to be substandard during the inspection, while 930 drugs met the required quality standards. These drug samples were collected from Himachal Pradesh, Odisha, Arunachal Pradesh, Meghalaya, CDSEO Baddi, Rishikesh, Ghaziabad, Bengaluru, Kolkata, Chennai, Mumbai, Ghaziabad, Ahmedabad, Hyderabad, and the Drug Department for inspection. The testing was conducted in the CDL (Central Drug Laboratory) and the inspection report was made public on Tuesday. Deputy Drug Controller Manish Kapoor has informed that notices have been issued to all the relevant pharmaceutical companies included in the Drug Alert, instructing them to provide reasons. Furthermore, directives have been given to recall the entire stock of the respective batches. Additionally, strict actions are being taken against those industries whose samples are repeatedly failing. Both units of Kanha Biotechnics have been shut down now, a month after the order to cease manufacturing.
List of drugs mentioned in the December drug alertMontelukast sodium and levocetirizine dihydrochloride tabletTelmisartan tabletPregabalin tabletCyproheptadine HCl and tricolinic citrate syrupSodium valproate tabletAmpicillin capsuleAmoxicillin trihydrate capsuleAscorbic acid + zinc capsuleTrypsin, bromelain and rutin trihydrate tabletBromhexol hydrochloride, terbutaline sulfate, guaifenesin and menthol syrup