India, often hailed as the "Pharmacy of the World," boasts a pharmaceutical industry renowned for its vast capabilities and significant global impact. With a market size around USD 50 billion and consistent growth averaging around 8-9% annually, India stands as a powerhouse in the realm of pharmaceuticals. India's pharmaceutical sector operates within a robust regulatory framework overseen by the Central Drugs Standard Control Organization (CDSCO) within Ministry of Health and Family Welfare in India and governed by the Drugs and Cosmetics Act, 1940, and Rules, 1945. The regulatory landscape is characterized by stringent quality standards, compliance requirements, and evolving guidelines to ensure the safety, efficacy, and quality of pharmaceutical products. Drug Controller General India (DCGI) is responsible for the drug license approval of drugs for import or manufacturing.
Classification of Drugs on the basis of Pharmacological Effect
In pharmaceutical effects they are classified on the basis of Effect they produce on the Human Body for ex- Analgesics (Relieves body pain), Antibiotics (Cure Infections), Antiseptics (Bacteriocidal or Bacteriostatic effect).
Legal Classification of Drug
· Schedule I - High potential of misuse or Addiction with no medical use
· Schedule II - High Potential of misuse but have some physical or psychological use
· Schedule III – Moderate to low potential misuse with psychological use
· Schedule IV – Low potential for dependence with good physical or psychological use
· Schedule V – The drugs used as analgesics, antitussive or antidiarrheal purposes with high physical use.
Therapeutic classification in India is in Alphabetical order which includes Acidifiers, Analgesics, Chelating Agents, Gastrointestinal Agents, Minerals, Pharmaceutic Aid, Stimulants, Vitamins, Wax Emulsifiers and many more drug Classification.
According to the types of medicine drugs are classified as Ayurveda, Unani, Yoga, Neuropathy, Homeopathy
Pharmacology classification by Chemical Makeup includes Alcohol, Opioids, Benzodiazepines, Cannabinoids, Barbiturates
Pharmacology Classification on the basis of Effect includes Depressent, Stimulants, Hallucinogens and Inhalants.
CDSCO governs the rules and regulations under the guidance of D&C Act and taken care by DGCI. In India, The manufacturer or importer needs to apply for form 44 application along with required amount of fees as guided in Schedule Y of D&C Rules for manufacturing or importing any new drug or its formulation for the purpose of marketing or performing any clinical trial in India.
CDSCO SUGAM Portal
The online portal used for licensing or registration processes by CDSCO named as “SUGAM” for the ease of submission, registration, processing, filing applications and fast servicing through online platform. Submissions, reviews and permission or NOC Granting are the services provided by SUGAM portal.
Importer, Indian agent, Enterprise holders or corporate people can register and be an applicant on the SUGAM portal. Manufacturing unit can not directly register through the portal. The Responsible person of the organization after registering gets the approval/ Verification through E-mail. For registering the RP have to submit ID proof, Address proof documents to CDSCO office. There is no need to register again if the person has CDSCO Approval.
Types of drug license under CDSCO Pharmaceutical Regulations in India
1. Wholesale drug license
2. Retail Sale Drug License
3. Manufacturing Drug License
4. Loan License
5. Import License
Documents required for obtaining drug sale license
a) Firm/Entity constitution, Company-Articles of Association (AOA), Memorandum of Association (MOA); LLP/Partnership- LLP or Partnership deed agreement
b) Owner/Proprietor/Director/Partner ID Proof
c) Property Ownership or Rental Agreement document
d) Any proof for storage, Refrigerator or Cold Storage availability.
e) Registered pharmacist affidavit
f) Premises Site plan and Key plan
g) Board resolution permit proof and challan copy
h) MPD 2021 Compliance Affidavit if the premise is located on DDA region
Documents required for retail sale pharmacist
a) Local pharmacy council registration
b) Letter of appointment
c) Qualification proof
Documents required for wholesale pharmacist
a) Letter of Appointment
b) Qualification proof
c) Certificate of Experience
Registration pathway for pharmaceutical products
1. New Drug Approval-
The Efficacy and Safety of the product is the first priority for approval process. It needs to check that the drug falls under the pharmacological activity and safe for human use. The CDSCO and Officer leader established Drugs Controller General (India) (DGCI).
Schedule Y under D & C rules give the information about requirements and guidelines for clinical trials which were further categorized as CATEGORY A (trials conducted in other market) and CATEGORY B (remaining ones fall under this category).
The drug approval process is comprised of two steps – a) Application for conducting clinical trial and b) Marketing Authorization request for drug from regulatory authorities.
The categories that adhere for the application process are Category A, B, C, D and E.
2. Certificate of Import Registration-
This registration is only for the importers wants to import drugs. Application is placed for issuing import registration certificate along with the required amount of fee to be paid with it. It can also be charged for the inspection fee and the DGCI either approve the GMP certification from the advanced countries such as EU, US or inspect on their own against Indian GMP. This process may take longer time.
3. License for Import-
The import license is to be issued by the foreign importers specified in Rule 10 and Rule 10A. Rule 24 of D&C Rules deals with requirements for obtaining license. Application is placed for import license before placing the importer must have Wholesale Drug License and other required licenses according to D&C Rules. Generally within 3 Months from the date of application the license is issued.
If a pharmaceutical product is approved in the European Union (EU) or the United States (US), it can facilitate the registration process for the same drug in India. The approval in a stringent regulatory authority like the European Medicines Agency (EMA) in the EU or the US Food and Drug Administration (FDA) is considered to be a significant milestone. Indian regulatory authorities often take such approvals into account while evaluating the drug for registration in India.
Clinical trial requirements in India for drug approval were governed by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act and Rules. Conducting clinical trials in India is an essential step in obtaining drug approval for marketing and commercialization. Here are some key requirements and guidelines for clinical trials in India:
Clinical Trial Approval: Prior approval from the CDSCO through the office of the Drug Controller General of India (DCGI) is required before initiating any clinical trial in India. The approval process involves the submission of a detailed Clinical Trial Application (CTA) with comprehensive study protocols, investigator's brochure, and other relevant documents.
Ethics Committee Approval: Besides regulatory approval, clinical trials must also be approved by an independent Ethics Committee (EC) registered with the CDSCO. The EC ensures that the trial is conducted in an ethical manner and protects the rights, safety, and well-being of trial participants.
Compensation and Insurance: Sponsors are required to provide appropriate compensation to trial participants in case of trial-related injuries or deaths. Additionally, clinical trial insurance is mandatory to cover any liabilities arising during the trial.
Good Clinical Practices (GCP): All clinical trials in India must adhere to the principles of Good Clinical Practice, as outlined by the International Council for Harmonisation (ICH-GCP) guidelines. GCP ensures the conduct of ethical and scientifically sound trials and the reliability of trial data.
Informed Consent: Prior informed consent must be obtained from each trial participant or their legally authorized representatives before their inclusion in the study. Participants must be informed about the trial's objectives, procedures, potential risks, and benefits.
Safety Reporting: Sponsors and investigators are required to promptly report any adverse events that occur during the trial to the regulatory authority and ethics committee.
Clinical Trial Registry: Registration of clinical trials in a publicly accessible clinical trial registry, such as the Clinical Trials Registry - India (CTRI), is mandatory before enrolling participants.
The permission to initiate clinical trial is typically granted (Form CT-06 or automatic approval in Form CT 4A) for a period of 2 years from the date of its issue, unless extended by the Central Licensing Authority.
Timeline
The time required for Import registration certificate is generally 9 months from the date of application. It takes about 180 days for the approval or registration of new drug. It takes about 3 months for the registration of cosmetic product.
Post Marketing Surveillance under CDSCO Pharmaceutical Regulations in India
Adverse Drug Reaction (ADR) Reporting: Healthcare professionals, including doctors, pharmacists, and other healthcare providers, are required to report any adverse drug reactions they encounter during the course of treatment.
Pharmacovigilance Program of India (PvPI): PvPI is a national program launched by the Central Drugs Standard Control Organization (CDSCO) to monitor the safety of pharmaceutical products in India. It operates through various Adverse Drug Reaction Monitoring Centers (AMCs) and Regional Pharmacovigilance Centers (RPCs) across the country. These centers collect, collate, and analyze ADR data and submit it to the Global database maintained by the Uppsala Monitoring Centre in Sweden.
Signal Detection and Analysis: Regulatory authorities, along with pharmaceutical companies and other stakeholders, continuously analyze the ADR data to identify potential signals or patterns of safety issues that may require further investigation or regulatory action.
Risk Evaluation and Mitigation Strategies (REMS): In certain cases where the drug's safety profile requires additional risk management, the regulatory authorities may implement REMS to ensure the safe use of the drug. REMS may include educational programs for healthcare professionals, patient medication guides, and other risk minimization measures.
Periodic Safety Update Reports (PSURs): Pharmaceutical companies are required to submit PSURs to the regulatory authorities at defined intervals. These reports summarize the safety data of the drug over a specific period and include an overall safety assessment.
As India's pharmaceutical industry continues to evolve, navigating the regulatory landscape remains crucial for stakeholders seeking to capitalize on market opportunities while ensuring compliance with applicable laws and regulations. With its dynamic market dynamics and regulatory expertise, India offers immense potential for pharmaceutical companies looking to expand their presence and make a meaningful impact on global healthcare.
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