Centre Proposes Overhaul of Drug & Medical Device Regulation Under New Bill

The government is developing a legislative overhaul to strengthen regulation across drugs, medical devices, and cosmetics. The proposed Drugs, Medical Devices and Cosmetics Act, 2025 is intended to replace the decades‐old 1940 Drugs and Cosmetics Act and introduce more stringent controls over the sector. 

At a high‐level meeting chaired by the Health Minister, the Drugs Controller General of India (DCGI) presented a draft of the new law. The reforms aim to empower the Central Drugs Standard Control Organisation (CDSCO) with statutory authority, tighten market surveillance, and enhance accountability across the regulatory ecosystem. 

Key features of the draft legislation include:

• Granting CDSCO the power for immediate enforcement actions against substandard, counterfeit, or falsified drugs and devices. 
• Digitization of licensing processes to streamline approvals and oversight. 
• Strengthened coordination between central and state regulators. 
• Upgrading laboratory infrastructure and testing capacity to ensure robust quality control. 
• Mandatory transparency and traceability throughout the manufacturing-to-market supply chain. 

A key impetus behind the reform is growing concern over product safety. India has faced scrutiny following cases such as child fatalities from contaminated cough syrup in Madhya Pradesh. 

According to CDSCO’s 2023–24 data, about 3.2% of around 5,500 tested drug samples were found substandard or spurious, leading to enforcement actions at over 40 manufacturing units in recent years. 

The government is expected to introduce the bill in the upcoming Winter Session of Parliament. If enacted, the law would align India’s regulatory framework more closely with global standards, boosting confidence in pharmaceutical and device exports. 

MDC Seeks SNCM, CDSCO Clarification on Midazolam Nasal Spray’s Inclusion in NLEM 2022

The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA) on pricing issues, has sought official clarification from the Standing National Committee on Medicines (SNCM) and the Central Drugs Standard Control Organisation (CDSCO) regarding the inclusion of midazolam nasal spray in the National List of Essential Medicines (NLEM), 2022.

This move comes after Noida-based Biodeal Pharmaceuticals Ltd applied for exemption of its formulation — midazolam nasal spray 1.25 mg — from price control under Para 32(iii) of the Drugs Prices Control Order (DPCO), 2013. The company argued that its product represents a new drug delivery system developed through indigenous R&D, making it eligible for a five-year exemption from price regulation.

However, the situation became complex when CDSCO confirmed that it had granted new drug approval to Biodeal for the formulation on May 5, 2025, while also clarifying that no other strength of midazolam nasal spray had been approved so far. The MDC, on the other hand, observed that the formulation was already listed in NLEM 2022, suggesting that it should have been an already approved drug.

To resolve this discrepancy, the Committee has asked both SNCM—which oversees the revision of NLEM—and CDSCO to provide their views on the approval status and the inclusion process of the drug in the 2022 list.

According to records submitted by Biodeal, the Subject Expert Committee under CDSCO had earlier noted that while midazolam tablets and injection forms were previously approved, the intranasal route had not been authorized before Biodeal’s application—indicating that their formulation was indeed novel.

In August 2025, CDSCO reiterated its position that Biodeal’s midazolam nasal spray 1.25% w/v was the only approved formulation to date. A follow-up communication on September 11, 2025, confirmed this once again.

The MDC emphasized that as per NLEM 2022 criteria, any drug included in the list must already be approved and licensed in India. Moreover, NPPA has already fixed a ceiling price for midazolam nasal spray based on market data showing at least three companies manufacturing or marketing the formulation.

In its September 16, 2025, meeting, the Committee concluded that further clarity from both SNCM and CDSCO is essential before proceeding. Once their inputs are received, the matter will be reviewed again by the MDC.

Under Para 32(iii) of DPCO 2013, manufacturers introducing a new drug with a novel delivery system developed through indigenous research can seek exemption from price control for five years from the start of commercial marketing.

CDSCO Suspended Manufacturing of Eye Drops of Global Pharma, Chennai

India's Central Drugs Standard Control Organization (CDSCO) has suspended the manufacturing of eye drops at the Chennai-based firm after US FDA allegedly linked 55 adverse events cases with contaminated eye drops.

The samples were taken for analysis from four batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium was also taken: Sources on 'Artificial Tears' eyedrops

The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of the investigation

During the investigation by senior drug inspectors, it was found that Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of 'Artificial Tears' to USA which were manufactured in 2021 and 2022

Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears.

Labeling Norms For Generic Drugs Changed: Health Minister

The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey through a written reply in the Lok Sabha informed about the labeling norms for generic drugs.

In order to ensure that the consumer is well informed about the generic medicine, Ministry of Health and Family Welfare published a draft notification for public comments vide GSR 302 (E) dated 30.03.2017 for amendment of Rule 96 to provide that the proper name of the drugs shall be printed in a conspicuous manner which shall be in the same font but at level two font size larger than the brand name or the trade name, if any. It will come to force after completion of due formalities as per the provisions of the Drugs and Cosmetics Act, 1940.

Indian Drug Manufacturers Association (IDMA) was invited to the stakeholders meeting held on 12.12.2017 in Central Drugs Standard Control Organisation (CDSCO) and they conveyed their inability to attend the meeting. However, they had already provided their suggestions/ comments on the draft notification vide letter dated, 11.05.2017 which has been received in the Ministry.

Applications for r-DNA derived Drugs via #Sugam Portal Now

Through a recent notification, CDSCO has said that the filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal

The authority has decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be accepted through online mode only from 1st Feb 2018 and no offline applications will be accepted after that.

On November 14, 2015, the Central Drugs Standard Control Organisation has launched an online portal SUGAM (www.cdscoonline.gov.in) in pursuance of the implementation of E-Governance.

The notice states that a reference is also invited to the stakeholders meeting held on 10.01.2018 wherein it has been agreed upon that, filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal.

In view of above, it has been decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs shall be accepted only through online mode from 1st Feb 2018 and no offline applications will be accepted thereafter.

Download Notification

#CDSCO Allows Relabeling of Old Medicines with Revised MRPs

Through a recent notice,  Directorate of General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare has clarified that pharmaceutical companies can relabel old stocks of their medicines with the revised Maximum Retail Prices (MRP) applicable following implementation of the Goods and Service Tax (GST) regime.

The notice implied that on receipt of representation received from FICCI dated 7.7.2017 on the subject Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service Tax (GST),this office has no objection for alteration of label (stickering) by the manufacturers under rule 104A of the Drugs and Cosmetics Rules, 1945, if required for implementation of GST subject to provisions of Legal Metrology Act & Rules and other provisions of Act and Rules relating to Goods & Service Tax.

In a circular last week the Ministry of Consumer Affairs, Food and Public Distribution had already stated that manufacturers, packers and importers of pre-packaged commodities should declare the post GST MRPs of unsold stocks which were manufactured, imported or packed before July 1.

There had been lot of confusion among chemist regarding selling price of medicine till now and they had been selling old stocks of medicines at their pre-GST MRPs even after implementation of GST on 1st July. Incidentally  pharma companies were expected to declare the new MRPs on the batches they manufactured after July 1. Attached below are relevant notifications concerning the issue.

CDSCO Notice GST :

Impact of GST on Unsold Stock of Pre-packaged Commodities:

15 Medical Devices Notified as Drugs for Price Regulation: #CDSCO

Through a recent notice, Central Drugs Standard Control Organisation (CDSCO),Directorate General of Health Services, Office of Drugs Controller General India has informed about 15 notified medical devices classifying as drugs bringing them automatically under price regulation.

On a notice dated June 29, 2017, CDSCO stated that The Drugs & Cosmetics Act, 1940 is an Act to regulate import, manufacture,distribution and sale of drugs and cosmetics. It extends to the whole of India. Further, the Drugs & Cosmetics Rules, 1945 have been put in place which are updated from time to time for uniform implementation of the statutory requirements

The devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central govt by notification in official gazette, after consultation with the Board, fall under the definition of drug.

The list of devices, so far are appended includes:

1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices for HIV, HbsAg and HCV
5. Cardiac Stents
6. Drug Eluting Stents
7. Catheters
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cements
11. Heart Valves
12. Scalp Vein Set
13. Orthopedic Implants
14. Internal Prosthetic Replacements
15. Ablation Device

The notice further informed that the health ministry has notified Medical Devices Rules, 2017, to bringing critical medical devices like stents, orthopaedic implants and diagnostic equipment under stringent regulation,which will come into force with effect from 1st day of January, 2018.

Criteria for Classification of medical devices including in vitro diagnostics have been specified in Rule 4, Chapter II of the rules which deals with regulation of Medical Devices in Indian context and in line with International Classification.

“It is expected that the importers, manufacturers, distributors and supply chain personnel shall voluntarily adhere with the safety, performance and quality aspects as stated in the said medical devices Rule, 2017 for creating proper eco-system for its effective regulation.In order to facilitate the process a special cell has also been created consisting of concerned JDC (I), DDC (I) and ADC (I) to address the issues, if any.” the notice added

A draft list of Medical Devices and in vitro diagnostics along with their risk based classification is annexed. Attached is the notification regarding the same.

Download Here

Three officials suspended for certifying drug as 'qualified'

Bengaluru, India 9 Sept 2014: The State Drugs Controller has recommended suspension of three officials – Junior Science Officer, Government Analyst and Chief Scientific Officer – for allegedly certifying a drug as ‘qualified’ despite negative report in the test and analysis.

Health and Family Welfare Department Principal Secretary N Sivasailam has submitted before Upalokayukta that the case will be entrusted to Lokayukta for disciplinary enquiry as per service rules.

An enquiry conducted by the Upalokayukta Justice Subhash B Adi had found that drug samples of Ccliya (Clomifene Citrate tablets) were certified as ‘qualified’ despite negative report in the test and analysis.

The complaint was that Chief Scientific Officer (CSO) Sudha Swamy had pressurised Government Analyst Mohammed Saifuddin Rubbani and Junior Scientific Officer Girish M K to prepare a positive report in the testing and analysis of the drug.

The drug samples of Ccliya, used in fertility treatment, was sent back to Government Analyst for repetition of test and analysis. After three repeated tests, CSO approved the report and the message was made known to retailers, wholesalers, manufacturers to prevent the sale of the drug.

However, one more test was conducted and the report was dispatched as “test passed.’’ Drugs Controller Raghurama Bhandary on Tuesday submitted a report stating all the three staff of the State Drugs Testing Laboratory were responsible for arbitrary and negligent testing.

“She (Sudha Swamy) has failed to report to higher authorities regarding approval of the test report as Not of Standard Quality and changing it to Standard Quality even after Not of Standard Quality report information had reached the public domain by way of SMSes and web publication,” the report said.

Upalokayukta Justice Subhash B Adi said the Principal Secretary has assured action within 15 days.

“In view of the submission by the Principal Secretary for Health and Family Welfare Department and promising action to be taken both of disciplinary enquiry as well as criminal proceedings if necessary against the officers, the matter has been posted for further hearing on September 30,” he said.

Govt to set up pharma zones at ports

The government of India is planning to set up dedicated pharma zones at airports and sea ports to facilitate import and export of pharmaceuticals, Central Drugs Standard Control Organisation Drug Controller General of India Surendra Singh said today.

 

The pharma zone would be initially set up at airports in Delhi, Mumbai and Chennai and would have dedicated area only for pharmaceutical products, Singh told reporters here. The ‘macro layout’ had been deliberated upon, but the details would be taken up for discussion at a meeting scheduled to be held in New Delhi shortly where all the stake holders including private developers, import-export traders, custom officials were expected to attend, he said.

The layout is expected to be frozen in June and it is up to the private developers to decided on the operationalising of the zone. Each zone is expected to require an investment of

Rs seven crore per zone, he added.Moreover, the zone would have facility to store drugs in cool temperature of 20-25 degrees to prevent of the pharamaceutical, he pointed out.

It would also have facilities for screening of drugs, a sampling area and would also house a port office for facilitating import and export of drugs, Singh said.

Singh also announced the setting up of a port office in Bangalore airport for facilitating import and export.

He said earlier all the drugs had to be shifted from here to Chennai for shipment abroad leading to overhead cost and delays. Such a facilty would help in cutting time on shipment time and cost factor, he said.Initially,the port would have a senior drug inspector and two trainee inspectors and there would be additional manpower added if the volume increased. The facility spread is expected to be operationalised in two weeks' time, he said.

As part of its overall exercise at strengthening the pharmaceutical industry and India's image in the global market as a reliable and credible source of drugs, there is plan to upgrade the current Hyderabad and Ahmedabad subzonal office as zonal offices.

taking the number of zonal offices to six, Debashish Panda, Joint Secretary, Drugs, Ministry of Health and Family Welfare, said. There were plans to set up new sub zonal office in industrial area of Baddi, HP and upgrade the port office as sub-zonal office in Karnataka.

The setting up of the facility would help in facilitating license approval, inspection of clinical trial audits, clinical monitoring devices,he said. The Indian drug and pharma manufacturing was estimated to be around 15 to 18 bn USD.Fifty percent of production account for exports.

Government bans drug

Imphal, India: The State Government has banned sale and distribution of Manrovisc Opthalmic Solution; Batch No MCP-8116, expiry date August 2010, manufactured by M/s Health Biotech (P) Ltd, Sandholi, Baddi District, Solan HP under Mfg Lic No MB/05/158 .

With reference to an order of Central Drugs Standard Control Organisation (East Zone), Government of India, State Drugs Controller of Director of Health Services Manipur has issued an order today in this regard.