India - Pharmaceutical Regulations and Registration Process

Due to Covid-19, there has been rapid growth in the pharmaceutical industry since 2019. The Pandemic led the increase in use of AI/ML applications and has also led to emergence of new E- Pharmacies are in India. By 2024 the pharmaceutical market in India is expected to grow by $65 billion. Pharmaceutical regulations and registration are governed by Central Drugs Standard Control Organization (CDSCO) within Ministry of Health and Family Welfare in India.


The Sale, Manufacturing and Distribution of API and Pharmaceuticals are regulated under Drug & Cosmetics Act 1940 and D & C Rules 1945. 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.


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

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.


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.

At Artixio, our team of experts try to understand every aspect of the novel or generic products in context of Indian market and provides high quality end-to-end solutions regulatory solutions for registration and post approval maintenance of pharmaceutical products.