Principle
The principle on which the Drugs & Cosmetics Act function is by a system of licensing under which all the activities involved in manufacture, sale and distribution of Drugs & Cosmetics are controlled.
Drug regulatory system in India
Drug is in concurrent list of Indian Constitution. It is governed by both Centre and State Governments under the Drugs & Cosmetics Act 1940 & Rules 1945 there under.
The mission of regulatory authorities is to promote and protect public health. The lack of access to medicines remains a huge concern, whether these are essential medicines, vaccines, orphan drugs or drugs for tropical diseases.
To facilitate access, regulators and all other stakeholders need to be actively involved in identifying difficulties and seeking solutions leading to balanced approaches to access which do not compromise public health safeguards.
Regulators have a role and responsibility to facilitate access to drugs of public health importance including proposing changes to the respective regulations in order to facilitate access without compromising quality, safety and efficacy.
As part of the medicines approval process, regulators should carry out an appropriate risk benefit assessment to allow for adjustment to the needs and profile of the anticipated patient populations.
New Drugs, SND, FDC, API, Bulk Drugs, Test Licenses, BE NOC, etc. for importers, manufacturers and traders
Regulatory support for FSSAI. Import assistance, Licensing and registration, FSSAI compliance, Product Approval
Medical device registration, Import license, Clarification from CDSCO, Performance evaluation
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
R.P/C.P
The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist in case of retail drug license and in case of wholesale a graduate with 1 years experience or undergraduate having four years experience is must or any Diploma or Bachelor degree in Pharmacy.
Area For Drug Licence
For opening a pharmacy business, the carpet area of the pharmacy must be a minimum of 10 square meters, and in case the application is for both retail and wholesale pharmacy the minimum area prescribed in 15 square meters. The premises must be commercial and adequately ventilated.
I had been struggling to navigate the complex and ever-changing landscape of Indian regulatory services for years, until I found a reliable partner in Barrolex Consultants. Their team of experts not only helped me understand the intricacies of various regulations, but also provided invaluable.
I recently purchased a Miscellaneous product from this company and was blown away by the quality and attention to detail. The product exceeded my expectations and has been an essential part of my daily routine ever since.
cannot recommend Global Regulatory Services enough. Their team of experts provided us with invaluable guidance and support as we navigated the complex and ever-changing regulatory landscape. Thanks to their expertise,
Proactively revolutionize granular customer service after pandemic internal or "organic" sources. Distinctively impact proactive human capital rather than client-centered benefits.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
