Drug Registration Process In India: A Guide For The Indian Drug Market
The drug registration process in India involves rigorous evaluation by the Central Drugs Standard Control Organization (CDSCO) to ensure safety, efficacy, and quality before granting approval for marketing and distribution.
The pharmaceutical industry in India is a dynamic and rapidly growing sector, offering significant opportunities for drug manufacturers worldwide. With a large population and increasing healthcare awareness, India presents a lucrative market for pharmaceutical products.
India’s pharmaceutical industry ranks third in production volume, growing steadily at about 9.43% annually for nine years. Key segments include generics, over-the-counter medicines, and vaccines.
India supplies more than half of the world’s vaccine demand, 40% of the US generic demand, and a quarter of the UK’s medicine supply. With a vast pool of scientists and engineers, India plays a vital role in the global pharmaceutical industry. Renowned as the “pharmacy of the world,” India offers affordable, top-quality medicines.
This article explores why India is an attractive market for drug manufacturers, the advantages and challenges they may encounter, and provides a comprehensive guide to the drug registration process in the country.
The Indian drug market
The Indian pharmaceutical market is projected to grow to US$ 65 billion by 2024, US$ 130 billion by 2030, and US$ 450 billion by 2047. Currently valued at around US$ 50 billion, with over US$ 25 billion from exports, India supplies 20% of global generic drugs.
The following pointed details give a clearer idea of the Indian drug market.
- India ranks among the top 12 biotechnology destinations globally and aims for a US$ 300 billion economy by 2030.
- The biosimilar market is expected to reach US$ 12 billion by 2025, comprising 20% of India’s pharmaceutical market.
- India is the 3rd largest API producer globally, contributing 8% to the industry.
- The medical devices sector is valued at US$ 11 billion, with plans to reach US$ 50 billion by 2030.
- India dominates the global pharmaceutical sector, supplying 20% of generics and 60% of vaccines.
The following chart simplifies the Indian drug market from 2021 to 2030
Indian pharmaceutical market (US$ billion)
Why choose India as the market for your drugs?
India is increasingly becoming the preferred destination for foreign pharmaceutical companies due to its vast population, expanding healthcare infrastructure, and rising demand. With a well-established regulatory framework and lower production costs, India offers opportunities for market expansion and access to a diverse patient population, making it an attractive choice for pharmaceutical companies.
Below are some reasons why you should choose India as the market for your drug.
- India is one of the largest pharmaceutical markets in the world, home to over 1.3 billion people.
- Rising healthcare expenditure- As India’s economy grows, so does its healthcare expenditure.
- The government’s efforts to modernize the healthcare system and the rise in disposable income present numerous opportunities for the pharmaceutical industry.
- India’s strategic location makes it an ideal hub for pharmaceutical companies looking to expand their presence in Asia.
- With a well-established network of suppliers, distributors, and contract manufacturing organizations, India offers access to neighboring markets.
Challenges in the Indian drug market
- Regulatory complexity: The regulatory landscape in India can be challenging, with multiple agencies involved in the drug approval and registration process.
- Affordability: Balancing the need for affordable drugs with maintaining profitability is a constant challenge, particularly in a market with diverse socio-economic segments, impacting accessibility to essential medications.
- Quality control: While India has made significant strides in improving the quality standards of its pharmaceutical products, concerns about product quality and counterfeit drugs persist.
New Drug Categorization in India
There are four categories of medicinal products in India.
- Promising New Drugs (ND)
- Subsequent New Drug (SND)
- Fixed-Dose Combinations (FDC)
- Investigational New Drug (IND)
Under Indian regulations, several products, though not new by Western standards, must still undergo the new drug application process. These include:
| Category A | Drugs not previously marketed in India |
| Category B | Drugs with new therapeutic purposes or dosages |
| Category C | New fixed-dose combinations of drugs |
| Category D | Drugs or formulations approved within the last four years, excluding those listed in the Indian Pharmacopoeia |
| Category E | All vaccines, unless certified otherwise by the DCGI |
Prerequisites to market a drug in India
In India, there are several prerequisites for selling pharmaceuticals. Meeting these prerequisites ensures compliance with Indian regulations and facilitates successful marketing.
- New Drug Approval (NDA): Obtain approval from the Central Drugs Standard Control Organization (CDSCO) by submitting a New Drug Application (NDA) dossier containing comprehensive data on safety, efficacy, and quality.
- Clinical trials: Conduct clinical trials following the guidelines laid down by the CDSCO, ensuring safety and efficacy data for the drug.
- Quality control: Ensure adherence to Good Manufacturing Practices (GMP) for manufacturing facilities and quality control processes to maintain consistent product quality.
- Regulatory compliance: Comply with all relevant Indian laws and regulations about drug registration, labeling, packaging, and advertising.
- Documentation: Prepare and submit all required documentation, including detailed information on the drug’s composition, manufacturing process, stability data, and labeling information.
- Labeling and packaging: Ensure that the drug’s labeling and packaging meet the requirements specified by Indian regulations, including accurate information on composition, dosage, storage conditions, and precautions.
- Post-market surveillance: Implement post-market surveillance activities to monitor the drug’s safety and efficacy in real-world settings and report any adverse events to regulatory authorities.
Documents required for registration
New drug application content varies based on the category of new drug. For any category, all new drug applications must have the following information:
- Drug name
- Dosage form
- Composition of formulation
- Test specifications for Active ingredients & Inactive ingredients
- Pharmacological classification
- Indications
- Manufacturer(s) of raw materials
- Applicable patents, if any
The drug registration process in India
Registering a drug in India becomes manageable with a clear grasp of the steps involved. Following flowcharts and relevant information can enhance comprehension, making the process more accessible.
Preparation phase
- Identify the drug(s) to be registered, considering market demand, therapeutic value, and regulatory requirements.
- Gather the necessary documents, including formulation details, manufacturing process, stability data, and clinical trial results, according to the guidelines of the Central Drugs Standard Control Organization (CDSCO).
Submission of application to CDSCO headquarters
- Prepare the application dossier in the prescribed format, including the Common Technical Document (CTD) format for new drug applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for generic drugs.
- Apply for the CDSCO through the online portal, along with the requisite fees and supporting documents.
Review and evaluation by the committee
- The CDSCO conducts screening of the application to ensure completeness and compliance with regulatory requirements.
- A thorough technical evaluation includes quality, safety, and efficacy data.
- Depending on the nature of the application, the CDSCO may conduct inspections of manufacturing facilities to verify compliance with Good Manufacturing Practices (GMP).
Approval of the application
Upon satisfactory evaluation, the CDSCO grants marketing approval for the drug, allowing it to be marketed and sold in India.
Starting the clinical trial
Test the new drug on volunteers to see if it’s safe and effective under controlled conditions.
Application for new drug registration to CDSCO
Submit paperwork to the Central Drugs Standard Control Organization for approval to sell the drug in India.
License is granted
Once approved, receive permission to market and sell the drug in India.
Import registration certificate and license
In India, importing drugs necessitates acquiring both an Import Registration Certificate and an Import License. The Import Registration Certificate, obtained from the DCGI, is linked to the drug’s manufacturing site and may prompt site inspections. While the DCGI typically trusts GMP certification from advanced countries, inspections are more common for drugs from low-cost countries.
The Import License, essential for customs clearance, varies based on the drug type and to ensure compliance with shipment testing requirements before entry through designated ports.
Regulatory information and compliance
- The CDSCO, under the Ministry of Health and Family Welfare, is the primary regulatory authority responsible for drug approval and registration in India. Additionally, state drug control authorities oversee regulatory compliance at the regional level.
- The Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 govern the regulation of pharmaceuticals in India. These laws outline the drug registration, manufacturing, distribution, and sale.
- Drug manufacturers must comply with regulatory requirements, including GMP guidelines, product labeling regulations, and pharmacovigilance obligations. Non-compliance can result in regulatory sanctions, including product recalls and fines.
Timeline and fees
The Indian drug registration timeline can vary. The following table gives a general idea of the timeline. Fees depend on factors such as the drug type and clinical trial phases, ranging from thousands to lakhs of rupees.
| New drugs/ Investigational new drugs | Targeted internal timeline in working days |
|---|---|
| IND application in consultation with the subject expert committee | 30 |
| New drugs including biological/ clinical trials/ new claims in consultation with the subject expert committee | 90 |
| Subsequent new drugs with the subject expert committee | 90 |
| Fixed dose combination in consultation with the subject expert committee | 90 |
Conclusion
Despite the challenges, India’s pharmaceutical market offers immense opportunities for drug manufacturers seeking to expand their global footprint. By understanding the regulatory landscape, navigating the drug registration process effectively, and addressing compliance requirements, companies can unlock the full potential of this dynamic and vibrant market.
Do You Have Any Questions Regarding The Drug Registration Process In India?
If you have any questions or need more details about the drug registration process in India, Credevo can provide comprehensive assistance. Our expert team members can offer guidance on various aspects of the process. Feel free to reach out for a thorough understanding of your specific needs by providing your requirements in the form below.