Drugs and Cosmetics Litigations
Introduction to drugs and cosmetics cases allied laws
The Drugs and Cosmetics Act of 1940 and Rules of 1945, which regulate the manufacturing and sale of drugs and cosmetics, are at the core of Mace's expertise. The Act contains comprehensive provisions for regulating the manufacture, storage, sale and distribution, stock, and offer for sale of drugs and cosmetics. The Act further provides for Ayurvedic preparations, Homeopathy medicines, and Medical devices, all of which Mace is well-versed in.
The Act is a complete Code in itself. It provides detailed procedures and statutory compliances for the prosecuting agencies and imposes obligations on the aggrieved persons to comply diligently with specific requirements. The operating procedures are found in the Rules of 1945. The elaborate rules for various kinds of drugs, cosmetics, and blood banks set the procedures to be adopted by the drug authorities.
With the introduction of the Cosmetics Rules, 2020, provisions from the Drugs and Cosmetics Rules 1945 were deleted, and new sets of rules called Cosmetics Rules, 2020, were created. There has been a significant change in the regulation of medical devices. The ‘Medical Devices Rules,2017’ are now being implemented, which manufacturers of medical devices are required to comply with. These changes are crucial for all stakeholders in the industry to be aware of. For new drugs, separate rules have been framed, i.e. New Drugs and Clinical Trial Rules, 2019 and put into force.
Prosecution for Not Standard Quality (NSQ) drugs, New Drugs and Fixed Dose Combination (FDC), License Suspension and Cancellation, Trademark, Patent and Copyright disputes, etc., are significant areas that found their way to litigation in the Court of law.
The following disputes are witnessed by pharmaceutical companies under the D&C Act 1940:
01
Prosecution in drug matters
02
Drugs not of standard quality
03
Spurious drugs
04
Adulteration of drugs
05
Misbranded drugs
06
Manufacturing without license
07
Counterfeit drugs
08
Prosecution after shelf-life expiry
09
Suspension,Cancellation and Restoration of Licenses
10
Challenging sample for CDL testing
11
Late testing of sample near expiry
12
Effect of Indian Pharmacopeia and other such standards
13
Appointment of drug inspectors
14
Directors’ Responsibilities
15
Dispensing by Doctors
16
Schedule K compliances
17
Food and Drug Dispute
18
Sanction by the Controlling Authorities
19
Prosecution without sanction of Controlling Authority
20
Prosecution against the Directors
21
Prosecution without power or jurisdiction
22
Plea bargain
23
Police power to register FIR
24
Imposition of ban on the sale of drugs in the state by the state authorities
25
Imposition of quantitative restriction on the drug that can be stored
26
FDC Banned under Section 26A
27
Directives under section 33P
28
Advertisement of drugs under schedule H or H1
29
Pharmacovigilance compliances
30
Blacklisting in tender process
31
Medical device manufacturing without license
32
If a product is a Drug of Food
33
Applicability of NDPS
34
Marketers responsibilities
35
Bail in drug cases
Other Practice Areas
Our global presence is supported by highly qualified professionals specializing in various areas of legal practice.
- New drugs and clinical trial, 2019
- Medical devices rules, 2017
- Drafting and vetting of contracts
- Publication of commentary on pharmaceutical and allied laws
- Publication of commentary on pharmaceutical and allied laws
- The Drugs and Magic Remedies Act, 1954
- Pharmaceutical patent
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