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30/09/2024

CDSCO TO SWITCH FORM 44 SUBMISSION ONLINE TO STREAMLINE REGULATORY SUBMISSION PROCEDURE

• In an effort to streamline the regulatory submission procedure with the Central Drugs and Standard Control Organisation (CDSCO), the veterinary division of the drug regulatory office has announced that it is switching submission of Form 44 for grant of permission to import or manufacture a new drug from offline to online mode.

• The facility of offline submission of application in Form 44, Form 45A/46A, Form 45/46 and Field Trial Permission for veterinary purpose only in hard copy or through e-office may not be available for processing, said the veterinary division of CDSCO.

• "In order to streamline the regulator submission procedure, the submission of application for issuance of new drug permission of vaccines/drugs for bulk (API) in Form-45A/46A and finished formulation in Form-45/46 and field trial permission is now functional on online system of Sugam Portal," it added.

• The applicants seeking such certificate, approval or permission shall apply through online portal as per the checklist in the developed modules.

Your compliance with this online submission protocol is essential for regulatory alignment and efficiency. For expert guidance and personalized support, contact us at [email protected]
Explore our comprehensive services at www.acplgroupindia.com
+91-9266665201, +91-9310040434

23/09/2024

Draft Guidelines on Good Clinical Practices - regarding

Central Drugs Standard Control Organization had constituted a committee under Chairmanship of Dr. Bikas Medhi, Prof. Department of Pharmacology, PGIMER, Chandigarh for the revision of India GCP guidelines and related guidelines in-line with New Drugs and Clinical Trial Rules, 2019 and currently available international guideline.

After detailed discussion, the committee has prepared draft guidelines on Good Clinical Practices. The committee opined that the proposed draft guidelines may

be circulated to various stakeholders by placing it on CDSCO website for seeking

comments before finalization of the guidelines.

Accordingly, the said draft guidelines on Good Clinical Practices is being published on CDSCO website for your comments/suggestions within period of 30 days by email to [email protected].

Your compliance with this online submission protocol is essential for regulatory alignment and efficiency. For expert guidance and personalized support, contact us at [email protected]
Explore our comprehensive services at www.acplgroupindia.com
+91-9266665201, +91-9310040434

19/09/2024

New Regulatory Guidelines for Marketing Practices of Medical Devices

Your compliance with this online submission protocol is essential for regulatory alignment and efficiency. For expert guidance and personalized support, contact us at [email protected]
Explore our comprehensive services at www.acplgroupindia.com
+91-9266665201, +91-9310040434

17/09/2024

Revised GMP norms for small drug firms to be issued soon; to be effective December

"Already GMP is applicable for bigger companies that have annual turnover of 250 crore or above. The government notified the GMP guidelines last year on 28 December. However, smaller firms were given time for one year to create an enabling environment to comply with GMP rules. A revised version of the GMP at par with WHO standards is in the works and will shortly be notified to be effective from December onwards," a government official aware of the matter said.

Your compliance with this online submission protocol is essential for regulatory alignment and efficiency. For expert guidance and personalized support, contact us at [email protected]
Explore our comprehensive services at www.acplgroupindia.com
+91-9266665201, +91-9310040434

16/09/2024

Wishing a happy Vishwakarma Puja to all! May Lord Vishwakarma's creativity and innovation inspire us to achieve greatness.

11/09/2024

CDSCO launched series of digital initiatives to streamline pharmaceutical regulations: DCGI

The Central Drugs Standard Control Organization (CDSCO) has launched a series of digital initiatives aimed at revolutionizing the pharmaceutical regulatory framework in India. These initiatives, showcased at the iPHEX 2024 event, are designed to enhance transparency, improve efficiency, and ensure the highest standards of safety and quality in the pharmaceutical sector, stated Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi.

Your compliance with this online submission protocol is essential for regulatory alignment and efficiency. For expert guidance and personalized support, contact us at [email protected]
Explore our comprehensive services at www.acplgroupindia.com
+91-9266665201, +91-9310040434

09/09/2024

Pharmaceuticals Department again extends deadline for self-declaration by companies

The Department of Pharmaceuticals (DoP) has again extended the deadline for self-declaration scheme under the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) for industry to September-end. Extending the time from the first published date of June 30 the self-declaration is to be signed by the executive head of the company regarding compliance to the UCPMP for the financial year 2024-25.

For Information Call Us +91-9266665201, +91-9310040434

Please email us at [email protected] for knowledgeable advice. Check out all of our offerings at www.acplgroupindia.com

07/09/2024

Wishing a prosperous and successful year ahead, with Lord Ganesha's blessings. Ganesh Chaturthi wishes!

05/09/2024

शिक्षक दिवस की शुभकामनाएँ !!!

शिक्षक दिवस पर, हम उन शिक्षकों को मनाते हैं और धन्यवाद देते हैं जिनकी मार्गदर्शकता और समर्थन हमारे सफलता के मार्ग को आकार देते हैं।

02/09/2024

India bans 156 combination drugs used to treat fever, cold, allergies

• The Centre has banned 156 widely sold fixed-dose combination (FDC) drugs used to treat fever, pain, cold and allergies, saying they were "likely to involve risk to humans.

• FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as "cocktail" drugs.

• The decision was made after an expert committee and the apex panel, the Drugs Technical Advisory Board (DTAB), found that these combinations, including antibacterial medicines, lacked therapeutic justification and posed risks to human health.

Please email us at [email protected] for knowledgeable advice. Check out all of our offerings at www.acplgroupindia.com
+91-9266665201, +91-9310040434

Address

B-3, Sector-6 Gautam Budh Nagar
Noida
201301

Website

http://www.acplgroupindia.co.in/

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