logo
New Schedule M rules: Most drug companies not yet ready for upgrade

New Schedule M rules: Most drug companies not yet ready for upgrade

Time of India08-05-2025

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.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Unlicensed medical shop raided in Hyderabad; drugs worth Rs 25,000 seized
Unlicensed medical shop raided in Hyderabad; drugs worth Rs 25,000 seized

United News of India

time4 hours ago

  • United News of India

Unlicensed medical shop raided in Hyderabad; drugs worth Rs 25,000 seized

Hyderabad, June 11 (UNI) Officials of the Drugs Control Administration (DCA), Telangana, raided an unlicensed medical shop operating at Zamistanpur, Musheerabad, Hyderabad, and seized a large quantity of medicines stocked illegally for sale. Acting on credible information, DCA officials conducted a raid on Tuesday at New Al-Shifa Medical and General Stores, located near Bandham Function Hall. The shop, operated by Mohd Saddam Hussain, was found to be functioning without a valid drug license, in violation of the Drugs and Cosmetics Act. During the raid, officers found unauthorised stocks of 35 different types of medicines, including antibiotics, abortion kits, and habit-forming drugs such as Alprazolam and Tramadol tablets, along with IV fluids. The seized stock was valued at approximately Rs 25,000. The raid was carried out by a team comprising D Saritha, Assistant Director (Secunderabad), along with Drugs Inspectors P Renuka (Musheerabad), B Govind Singh (Secunderabad), G Anil (Malakpet), and M. Surendranath (Begumpet). Samples of the seized medicines were taken for analysis, and further investigation is underway. DCA officials have cautioned that wholesalers and dealers who supply medicines to unlicensed outlets will also face strict action. Supplying drugs to entities without a valid license is a punishable offence under the Drugs and Cosmetics Act, a DCA statement said on Wednesday. UNI VV RN

‘Expired items kept with others at Zepto facility'
‘Expired items kept with others at Zepto facility'

Time of India

time01-06-2025

  • 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.

Violations in drug sale rampant in Wanaparthy
Violations in drug sale rampant in Wanaparthy

Hans India

time31-05-2025

  • 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.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store