#DrugRegulation

[professionalutilities1]

What is a "CDSCO Drugs Import License"?

The responsibility for issuing licenses for Specialized Categories of Critical Drugs, including blood and blood products, I.V. fluids, vaccines, and sera, lies with the Central Drugs Standard Control Organisation and state regulators. Importing drugs into India necessitates a Drugs Import License, which must adhere to government regulations.

CDSCO holds the designation of being the National Regulatory Authority (NRA) in India. The regulation of Import, Manufacturing, Sale, and Distribution of Drugs in India is governed by the Drugs & Cosmetics Act of 1940 and Rules of 1945.

Benefits of CDSCO Drugs Import License:

Legal Compliance

Quality Assurance

Consumer Safety

Business Credibility

Supply Chain Integrity

Customs Clearance

Marketing Authorization

Documents of CDSCO Drugs Import License:

Covering Letter

Form 8 or 8-A

TR6 Challan

Testing Protocol

Product Label and Brochures

FSC Certificate in the Country of Origin

Notarized Agreement

Ethics Committee Approval

Original Power of Attorney

Plant Master File

Drug Master File

Copy of BA/BE site registration (as approved by CDSCO in case of BA/BE approved sites)

Manufacturing License or Wholesale License (in the case of Import)

[vigilarebiopharma]

Pharmacovigilance guidelines serve as essential frameworks and standards that govern the practice of pharmacovigilance globally. These guidelines provide guidance and recommendations for various stakeholders involved in drug safety monitoring, including regulatory authorities, pharmaceutical companies, healthcare professionals, and researchers.

[jsbmarketresearch01]

Government Could Ban Online Pharmacy Apps Like MediBuddy, NetMeds, Tata 1mg, and Others

E-pharmacy apps such as NetMeds, Tata 1mg, and others may soon face a ban over the sale of online medicine for violating the norms of the government. The Union Health Ministry in India is planning to take strict action against online drug stores that sell medications. This is because of increased concerns over malpractices, security concerns over privacy and data, as well as the baseless sale of medicines. A close source revealed that the government may propose a complete ban.

The revised draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023 is presently going through inter-ministerial consultation. And as per the proposal of the Central Government, it may prohibit or restrict, regular the same and distribution of any medication sold online or at e-pharmacies. The bill is intended as a replacement for the existing Drugs and Cosmetics Act of 1940. And the renewed draft disables the provision earlier listed in the old draft bill. Here permission was required to operate e-pharmacies.

In the old draft, it was noted that no person could sell, exhibit, offer for sale, stock, or distribute by himself on done by any other person on his behalf of him through e-pharmacy (online medical store) except under and in accordance with permission or license. The government wishes to have better control over the functioning of online pharmacies. It wants to set improved regulations and get rid of the irrational use of prescription medicines, as well as maintain the security and privacy of patient data.

Most online pharmacy apps collect data related to the region and area-wise details, medicine consumption, and others. And this increases the risk to the safety of the patient. Support to ban online pharmacies has found support from a group of ministers already. The proposed regulations are to ensure the safety and efficacy of medicines and growing concerns about them being sold in online pharmacies, which are otherwise not under proper regulatory mechanisms.

The decision to ban or regulate e-pharmacies is in regard to tensions about the security and privacy of patient data. The misuse of data is thus, the point of contention here. Some of the pharmacy apps, which are quite popular and may come under purview are Amazon, MediBuddy, Apollo, Tata 1mg, Flipkart, Practo, and NetMeds. They have already received show-cause notices from DCGI (Drugs Controller General of India) in February for violating norms over the online sale of medicines.

The DCGI order was sent to all Union Territories and States in November and May 2019, and then again on 3 February 2023, confirming them to comply with the norms of the government.

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[globalinstituteregulatoryaffairs]

Certification Program in Drug Regulatory Affairs:Join the course and Become a Drug Regulatory Affairs Expert,This program helps to provide comprehensive education on the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry.

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Who Can attend this course:

-Pharmaceutical industry employees

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-Diploma in pharmacy

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[globalcompliancepanel]

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The first stage of process validation is process design. The Process Validation guidance document states, "A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

[dalmedlibrarian]

Check out the Dalhousie School of Information Management’s upcoming public lecture, Fraud Forgotten? What the History of Drug Regulation Teaches Us About the Importance of Transparency Today, by Matthew Herder, associate professor in the Faculties of Medicine and Law. It’s taking place on November 4th, 12:00-1:00pm, in room 3089 in the Rowe Building. More details here: https://blogs.dal.ca/sim/2015/10/29/im-public-lecture-matthew-herder-dalhousie-medicine-law/

[globalinstituteregulatoryaffairs]

Confused to take a step ahead in your Career! We make it better for you, Make your career in the pharmaceutical industry. . . We provide certification courses in Drug Regulatory Affairs, Join the course and Become a Drug Regulatory Affairs Expert, . . Who Can attend this course: -Pharmaceutical industry employees -Pharmacy Students & Pharma Professionals -Chemistry students -Science Graduates -Diploma in pharmacy -Pharma professionals . . Register and start learning now. Admissions Open!! More info visit:https://bit.ly/3uiPCWK CALL/WHATSAPP For Enquiry: +91-9595750750 For Enquiry Email at info@regulatoryinstitute.com