Industries
The rules your product must meet
Each industry has its own rules. Find yours below. We show the main rules you face, and the services that help you meet them.
Industry
Pharmaceuticals
The rules you face
In India, medicines are controlled by CDSCO, the national drug regulator. The main law is the Drugs and Cosmetics Act, 1940, with its Rules.
New medicines and clinical trials follow the New Drugs and Clinical Trials Rules, 2019. Every trial needs approval from an ethics committee: a group that checks the study is safe and fair for the people in it.
To sell abroad, you need approval in each market. In the US, that is the US FDA. Once a medicine is on sale, you must watch for side effects and report them.
Services that help
- Regulatory affairs: Plan the route to approval and file with CDSCO and the US FDA.
- Clinical trials (CRO): Run studies in people, from Phase I to Phase IV.
- Pharmacovigilance: Track and report side effects once the medicine is in use.
- Accredited labs: Shelf-life, packaging and batch release testing.
- Microbiology studies: Sterility and preservative testing.
Industry
Medical devices and MedTech
The rules you face
In India, medical devices follow the Medical Devices Rules, 2017, under the Drugs and Cosmetics Act. Devices are sorted into four risk classes, from A (lowest risk) to D (highest risk). The class decides how you get a licence.
In the US, the US FDA clears most devices through routes such as 510(k) or De Novo. In Europe, devices must meet EU MDR, the EU Medical Device Regulation.
Once a device is in use, problems with it must be reported. In India, this is part of materiovigilance: watching for problems with medical devices.
Services that help
- Regulatory affairs: Classify the device and prepare CDSCO filings, US FDA routes and EU MDR technical files.
- Clinical trials (CRO): Run clinical investigations of devices.
- Human factors and packaging: Show that real people can use the device safely.
- Accredited labs: Packaging, transport and shelf-life tests.
- Pharmacovigilance: Report and track problems with devices in use.
Industry
Food and FMCG
The rules you face
FMCG means fast-moving consumer goods: everyday products such as food, drinks and personal care. In India, food is controlled by FSSAI under the Food Safety and Standards Act, 2006.
Cosmetics follow different rules. They come under CDSCO and the Cosmetics Rules, 2020.
Labels and claims are checked closely. A claim such as "kills germs" or "lasts 12 months" needs test results to back it up.
Services that help
- Regulatory affairs: Check labels and claims against the rules in each market.
- Accredited labs: Shelf-life and packaging tests.
- Microbiology studies: Preservative and antibacterial testing to back up your claims.
- Clinical trials (CRO): Efficacy studies for cosmetics: tests in people that show a product does what it says.
- Human factors and packaging: Child-resistant packaging tests.
Industry
Nutraceuticals
The rules you face
Nutraceuticals are health supplements and foods with an added health benefit. In India, they are controlled by FSSAI, not CDSCO.
They follow FSSAI's regulations for health supplements and nutraceuticals, first made in 2016.
A health claim must be backed by evidence. If your product treats or prevents a disease, it may count as a medicine instead.
Services that help
- Regulatory affairs: Decide which rules apply, and check labels and claims.
- Clinical trials (CRO): Efficacy studies that back up a health claim.
- Accredited labs: Shelf-life and packaging tests.
- Microbiology studies: Tests for germs and preservatives.
- Market access: Plan the launch and find distributors.
Industry
Biotechnology
The rules you face
Biotechnology uses living cells to make or test products. A biotech product that is a medicine goes through CDSCO, like any other medicine.
Work with genetically modified organisms (living things whose genes have been changed) has extra rules. In India, committees called RCGM and GEAC review it.
Early on, the hard part is often knowing which rules apply at all. Deciding this early saves time later.
Services that help
- Innovation and strategy: Turn a new idea into a plan: the science, the approvals and the evidence.
- Organoids and NAMs: Early safety and efficacy data from human cells.
- Regulatory affairs: Plan the route to approval.
- Accredited labs: Stability and method validation.
- Clinical trials (CRO): Run the first studies in people.
Industry
Biologics and vaccines
The rules you face
Biologics are medicines made from living cells, such as antibodies and vaccines. In India, they are approved by CDSCO under the New Drugs and Clinical Trials Rules, 2019.
Similar biologics (close copies of an approved biologic) have their own Indian guidelines. In the US, a new biologic needs a BLA (Biologics License Application) with the US FDA.
Vaccine batches are tested before release. Side effects after vaccination must be watched for and reported.
Services that help
- Regulatory affairs: Plan BLA and CDSCO filings.
- Clinical trials (CRO): Run studies in people, from early phases to Phase IV.
- Pharmacovigilance: Track and report side effects once the product is in use.
- Microbiology studies: Sterility, bioburden and endotoxin testing.
- Accredited labs: Stability studies.
Industry
AI in healthcare
The rules you face
If software is meant to diagnose, treat or monitor patients, it can count as a medical device. This is called software as a medical device. In India, such software can come under the Medical Devices Rules, 2017.
The US FDA and EU MDR also regulate medical software. They want proof that it works on data it has not seen before.
Health data is personal data. In India, the Digital Personal Data Protection Act, 2023 (DPDP Act) sets the rules for using it.
Services that help
- Regulatory affairs: Classify the software and prepare the dossier for each market.
- Clinical trials (CRO): Test the software's performance in real clinical settings.
- Real-world evidence: Gather evidence from everyday care with hospital partners.
- Human factors and packaging: Check that doctors and patients can use it safely.
- Innovation and strategy: Plan the evidence you need from the start.
Industry
Universities and research
The rules you face
Research with people needs approval from an ethics committee first. In India, ICMR (the Indian Council of Medical Research) sets the national ethical guidelines for this research.
Clinical trials in India must be registered with CTRI, the Clinical Trials Registry of India, before the first person joins.
If you want to turn your research into a product, the product rules apply too. Planning for them early saves time.
Services that help
- Innovation and strategy: Turn research into a product plan.
- Organoids and NAMs: Test on human cells, with fewer animal tests.
- Clinical trials (CRO): Help write the study plan and run the study.
- Real-world evidence: Set up registries and study data with hospitals.
- Regulatory affairs: File for approval for the first time.
Industry
Hospitals
The rules you face
Hospitals that host clinical trials must follow GCP (Good Clinical Practice): the international rules for running trials safely and fairly.
Ethics committees that review clinical trials in India must be registered with CDSCO.
Doctors and hospitals can report side effects of medicines to PvPI, India's drug safety programme. Problems with medical devices go to MvPI, India's device safety programme.
Services that help
- Clinical trials (CRO): Join our network of 50+ clinical trial sites.
- Real-world evidence: Build registries and studies from everyday care.
- Pharmacovigilance: Process and report safety cases.
Industry
Community healthcare
The rules you face
Community healthcare brings care to people where they live, often through health workers and local groups. We support community programmes such as cancer screening, and studies for rare diseases (orphan drugs).
Research in communities needs ethics committee approval. People must agree to take part after it is explained in a language they understand.
Personal and health data must be protected under the DPDP Act, 2023.
Services that help
- Real-world evidence: Gather evidence from everyday care in the community.
- Clinical trials (CRO): Run studies with people outside big hospitals.
- Pharmacovigilance: Collect and report side effects.
- Market access: Plan how a product reaches the people who need it.
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