New Schedule M rules: Most drug companies not yet ready for upgrade
With the revised Schedule M deadline approaching, only a fraction of small and medium pharmaceutical companies have submitted facility upgrade plans. The health ministry, concerned about the slow response, has urged state health secretaries to engage with local drugmakers. This aims to ensure broader compliance with the updated quality standards outlined in Schedule M of the Drugs and Cosmetics Act.
Tired of too many ads?
Remove Ads
Only a small number of pharmaceutical companies have submitted plans for upgradation of facilities even as a revised deadline for implementation of revised Schedule M ends on Monday. Health ministry officials said out of about 10,000 medium and small manufacturing enterprises, just about 100 have submitted applications.Health secretary Punya Salila Srivastava has now written to state health secretaries, asking them to issue necessary directions to state drug regulators to discuss the matter with drugmakers in their own areas.Schedule M of the Drugs and Cosmetics Act outlines quality standards for pharmaceutical products.This February, the ministry issued a notification extending the deadline for implementing revised Schedule M, whereby manufacturers with revenues of less than ₹250 crore were required to submit applications to the Central License Approving Authority within three months, along with their upgradation plans "However, as per the data available, very few firms have submitted their application requesting extension of timelines for implementation of revised Schedule M," said the health secretary in her letter to states.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
01-06-2025
- Time of India
‘Expired items kept with others at Zepto facility'
Expired items were also kept along with others at the facility, Anupama Patil, assistant commissioner (Food), said, adding that "They have since destroyed those products." The facility has been registered under its parent company Kiranakart Technologies Pvt Ltd. The licence suspension will remain in effect until Zepto demonstrates compliance with food safety regulations. "Till the contraventions are cleared, the facility will remain shut," joint commissioner (Food) Mangesh Mane said, adding that more inspection will be carried out at other Zepto warehouses besides other quick-commerce platforms. A spokesperson for Zepto said, "At Zepto, maintaining the highest standards of food safety and hygiene is non-negotiable. ...We have already initiated an internal review and are working closely with the authorities concerned to ensure full and swift compliance." The company said it is taking corrective action to rectify the lapses and resume operations in accordance with the law. In Jan, FDA raided three companies for the alleged sale of medicines without a licence through an online delivery service. Officials conducted raids at Foclo Technologies in Thane, Bhagwati Stores in Kandivli, and Scootsy (Swiggy) Logistics in Malad. Seven samples had been taken from the three premises, and the remaining stock of medicines, worth Rs 16,700, was seized. under provisions of the Drugs and Cosmetics Act, 1940, and Rules, 1945.
Hans India
31-05-2025
- Hans India
Violations in drug sale rampant in Wanaparthy
Wanaparthy: Monthly drug sales in the district have crossed the Rs 10 crore mark but all is not well in the business. A large portion of this sale is allegedly illegally driven by unlicensed medical shops operating without proper permits and proper oversight. Of the 320 medical shops in the district, more than 100 running unofficially. Over half of these are operating without proper licence. Moreover, medical shops are required to issue receipts for any purchase but there are allegations that receipts are not being provided and prices charged are above MRP. Generic medicines are being sold at high prices as if they are branded. 'The Drugs and Cosmetics Act is not being properly enforced, indicating a lack of supervision from ground-level drug control officers,' said a local. 'Even kirana shops are selling tablets,' said Ramesh, resident of Pebbair. 'In emergencies, they are exploiting people by charging high prices. Officials must act against such practices,' he said. Some medical shop operators are reportedly bringing in doctors from Hyderabad, Kurnool and other areas without any authorisation, using their names to attract patients and sell medicines. To run a clinic or hospital, DMHO approval is required. However, many shop-owners in the district are ignoring these regulations and are running businesses illegally, earning large sums by violating norms. Companies are reportedly making deals with shop-owners and doctors, offering commissions between 25% and 40% for selling their products. As a result, doctors are allegedly prescribing these medicines to patients regardless of necessity, focusing more on meeting company-imposed sales targets than on patient care. 'Violation of rules will lead to action,' warned Drug Inspector Rashmika. 'Last year, we registered 15 cases in the district. Some shops selling banned drugs have already been seized and are under court jurisdiction. People must insist on taking a receipt when purchasing medicines from any medical shop. Everyone should be aware of this,' she underscored.
Time of India
30-05-2025
- Time of India
Health ministry seeks report on preparedness for Covid-19 by June 2
New Delhi: As Covid cases continue to rise across the country, the union health ministry has asked several states and union territories, including Delhi, to put preventive measures in place. As of May 28, India recorded 1,621 active cases with Kerala, Maharashtra, Delhi, Gujarat, Tamil Nadu and Karnataka accounting for over 90% of total active infections. In a letter dated May 29 to state chief secretaries and UT administrators, health secretary Punya Salila Srivastava addressed the seasonal increase in respiratory illnesses caused by various pathogens, including Influenza, SARS-CoV-2 and RSV. "A notable but gradual increase in cases of acute respiratory illnesses (ARIs) due to SARS-CoV-2 is being seen in some parts of the country," the letter mentioned. She stated that most infections were mild, with current Omicron variants JN 1, XFG, and LF 7.9 causing typical symptoms of fever, cough and sore throat that resolve naturally. The letter instructed states and UTs to assess hospital readiness at district and sub-district levels, including medical colleges, tertiary care centres and other inpatient healthcare facilities. This includes ensuring the availability of diagnostics, essential drugs, PPEs, isolation facilities, oxygen supply, critical care beds and ventilator-supported beds. Facilities must conduct mock drills to verify oxygen preparedness. An action taken report has to be shared by June 2. The ministry emphasised following testing protocols as per operational guidelines: testing all SARI cases and 5% of ILI cases. SARI-positive samples have to be forwarded to regional VRDL centres for whole genomic sequencing. District Surveillance Units must monitor ILI/SARI trends, track SARI proportions among cases, and maintain regular data entry on the portal concerned. Through public health education, proper hand and respiratory hygiene practices, including appropriate cough etiquette and avoiding spitting in public, have to be promoted. Vulnerable groups, including elderly and immunocompromised individuals, should avoid crowded, poorly ventilated spaces or wear face masks in such environments. Also, individuals experiencing respiratory symptoms should monitor their health and seek medical attention if they develop serious symptoms like breathing difficulties or chest pain.
