Frequently Asked Questions — Drug & Cosmetics Lawyer in Delhi

Advocate Srijan Tiwari is a Delhi High Court advocate who specialises exclusively in drug and cosmetics litigation under the Drugs and Cosmetics Act, 1940. With 14+ years of dedicated practice since 2010, he represents pharmaceutical and cosmetics corporations — including domestic manufacturers, multinational companies, API producers, and generic drug firms — in litigation, regulatory disputes, and compliance advisory.

Drug and cosmetics law is a highly technical practice area requiring deep knowledge of pharmaceutical science, CDSCO procedures, pharmacopoeial standards, and the specific statutory framework of the Drugs and Cosmetics Act. A general practice firm handles this as one case among many. Advocate Srijan Tiwari has built his entire 14-year career around this singular focus — which means every precedent, every regulatory development, and every courtroom strategy is calibrated for drug law. That depth is impossible to replicate with a generalist approach.

Advocate Srijan Tiwari's practice is exclusively for corporate clients — pharmaceutical manufacturers, cosmetics companies, API producers, drug distributors at the corporate level, and multinational companies with Indian operations. Individual retail chemists, small traders, or individual patients are not within the firm's client mandate. This allows the practice to maintain its focus and resource level for complex corporate matters.

The office is based at Delhi High Court, New Delhi. This placement is deliberate — it allows Advocate Tiwari to be available for court hearings at the High Court on the same day, file urgent applications without delay, and respond rapidly to court orders. For clients based in pharmaceutical manufacturing hubs like Okhla, Narela, Bawana, or Wazirpur, the firm provides counsel remotely and visits as required.

NSQ stands for Not of Standard Quality under Section 16 of the Drugs and Cosmetics Act, 1940. When a drug or cosmetic product is found to fail the quality standards prescribed in the pharmacopoeia or manufacturer's own specifications, the drug authority can initiate prosecution. Consequences include criminal prosecution of company officers (directors, quality heads, authorised signatories), fines up to ₹10 lakh or more per offence, potential imprisonment in serious cases, and severe reputational damage. Companies without experienced counsel often find themselves convicted on weak technical grounds due to inadequate defence.

The most effective NSQ defences typically challenge: (1) Sample collection procedure — whether Form 29 was properly prepared, whether the sample was properly sealed, whether the chain of custody was maintained; (2) Drug testing methodology — whether the government analyst used the correct pharmacopoeial method, whether the analyst was qualified, whether the testing laboratory was properly accredited under NABL; (3) Technical standards interpretation — whether the alleged quality failure actually constitutes NSQ under the relevant pharmacopoeial specification; (4) Limitation — whether the prosecution was filed within the time limits prescribed by law. Advocate Srijan Tiwari assesses all of these angles in every NSQ defence mandate.

For active prosecution matters, the firm provides same-day response. If a client receives a court summons, a drug authority complaint, or learns of seizure of their product, they should contact the office immediately via WhatsApp (9899966225) for an urgent consultation. Bail applications, stay applications at Delhi High Court, and interim injunctions against enforcement can typically be filed within 24–48 hours of receiving instructions.

Yes. NSQ convictions at trial court (Magistrate Court) can be challenged through revision petitions and criminal appeals at the Delhi High Court. Additionally, where the trial court has not given adequate weight to technical evidence or expert testimony, or where there has been a legal error in the conduct of the trial, these grounds can be argued at the High Court. The firm regularly handles such appellate matters as part of its Delhi High Court practice.

Licence suspension by a state drug authority or CDSCO is a coercive regulatory action that can be challenged at multiple levels. First, the suspension order itself should be reviewed for procedural compliance — was the company given adequate notice? Was a hearing provided before suspension? Was the order made on valid legal grounds? If procedural requirements were violated, an immediate writ petition at the Delhi High Court can seek stay of the suspension order. Simultaneously, an appeal to the Drugs Technical Advisory Board or the Central Government (depending on the type of licence) can be filed. The firm handles both tracks — administrative and judicial — concurrently.

CDSCO quality alerts and drug recall orders under Rules 76, 77, and 77A of the Drugs and Cosmetics Rules can be challenged by writ petition at the Delhi High Court. The grounds typically include: absence of natural justice (no hearing before the order), the quality alert being based on a deficient or unauthorised testing report, jurisdictional excess, and violation of the company's procedural rights. The firm has experience in obtaining stay orders against CDSCO actions at the Delhi High Court, allowing companies to continue commercial operations while the challenge proceeds.

A show cause notice (SCN) from a drug authority must be responded to within the deadline specified (typically 15–30 days). The response is critical — it forms the foundation of the company's defence and can significantly influence whether prosecution follows. A strong SCN response will: identify the regulatory basis for the authority's action and challenge it if flawed; present technical facts (QC data, testing records, GMP documentation) to rebut the allegations; cite relevant legal precedents in the company's favour; and propose corrective actions where appropriate. Advocate Srijan Tiwari's team drafts SCN responses that are legally sound, technically rigorous, and strategically positioned.

Fee structures are matter-specific and depend on the nature of the case (prosecution defence, regulatory challenge, advisory), the court level (trial court, High Court), and the anticipated duration and complexity. For litigation, fees are typically structured in stages — initial retainer, appearance fees, and performance milestones. For corporate retainer arrangements, a monthly advisory fee is agreed covering a defined scope. Specific fee proposals are provided after the initial consultation. The firm's fees reflect its specialised expertise and are positioned for corporate clients rather than individuals.

Yes. Many clients are based in Mumbai, Hyderabad, Ahmedabad, and other pharmaceutical hubs — but have matters that arise before the Delhi High Court or CDSCO, both of which are based in Delhi. For matters that require local court presence in other cities, the firm coordinates with trusted advocates in those jurisdictions while maintaining strategic control of the matter from Delhi. Consultations, advisory, and strategy sessions are conducted remotely via phone and video call for clients outside Delhi.

For prosecution matters: the prosecution complaint or court summons, Form 29 (Government Analyst report), seizure memo, product batch records, and any prior correspondence with the drug authority. For regulatory disputes: the show cause notice or order, the company's drug licence, prior inspection reports, and any communications with the authority. For advisory mandates: a brief overview of the company's product portfolio, existing regulatory issues, and recent interactions with drug authorities. The more complete the picture, the more precise the initial legal assessment.

All client communications, case details, and documents are treated with strict attorney-client privilege confidentiality. The firm does not disclose client identities, case details, or outcomes to any third party without explicit client consent. Digital communications are managed through secure channels. Team members sign non-disclosure agreements as part of their employment. Corporate clients can also request specific confidentiality protocols — particularly for sensitive regulatory situations where public knowledge could cause market impact.

The best drug and cosmetics lawyer in Delhi should have exclusive or primary focus on drug law (not as a side practice), demonstrated experience at the Delhi High Court level, the technical knowledge to understand pharmaceutical quality standards and testing methodology, and a track record with corporate pharmaceutical clients. Advocate Srijan Tiwari meets all of these criteria — with 14+ years of exclusive practice, 500+ corporate clients served, and a team dedicated entirely to this practice area at Delhi High Court.