Generic Drug Assessment and Approval Process in India

Generic Drug Assessment and Approval Process in India

Generic drug is the medicine that is created identical to the already existing drug in the market. The ingredients of these medicines are similar to the branded medicine and can conclude that the generic medicines are substitute of branded medicine. As it is similar to the branded medicine their effects and clinical benefits are similar. Moreover, the generic medicines are cost effective; therefore, it can reach to the people of all classes. Now, here the most important and obvious question arises that despite the same ingredients are used why these medicines are cheaper than branded?  The generic medicines are cheaper because various initial steps is eliminated while manufacturing generic medicines such as clinical trial, animal testing etc. and that results in deduction of cost.

Why there is a need to manufacture generic medicine in India?

By approving various generic medicines available by different companies, Food and Drug Administration (FDA) create competition in the market and that eventually leads in easy availability of drugs in the market at lower cost. Drug Competition and Action Plan (DCAP) is introduced by FDA to ensure healthy generic market in the country so that the patients can have the access to these medicines at affordable price. The plan mainly works on the three functions:

  • Improving the competence of the generic drug development, review and approval processes.
  • Updating regulatory requirements for generic drugs while maintaining evidence based medicine practice.
  • Work on the loopholes that branded medicine creates for delaying generic drug approval.

Why the generic license is not approved just after the launch of brand name medicine?

A lot of expenditure is incurred while manufacturing a new drug on research and clinical trial, so it is essential to recover the cost of manufacturing from that drug. And by getting patent right the company protect the drug from being copied. Therefore the generic license is not approved just after the manufacturing of branded drug.

What information needed to be submitted for approval of generic medicine?

The manufacturer needs to submit the manufacturing process to the FDA for ensuring that they are manufacturing high quality product identical to the branded medicine. Additionally, they have to submit the details regarding the active and inactive ingredients present in the generic medicine.

In addition to this, the manufacturer has to conduct human study and the submission of same is required. The human study includes voluntarily taking of both generic and branded medicine so that the safety and quality can be ensured.

After submission of the above information the professionals and scientists check the data collected for analysing the quality and efficiency of generic drug. If the company needs to change any particular thing in the drug the change needs to be notified to the authorities.

What is the criterion for granting FDA approval?

  1. Before granting approval to any generic medicine it is ensure that the active ingredient used in the medicine is same as of the brand name medicine and will work effectively after consumption. Also, the inactive ingredient used in the medicine is safe for consumption and will leave no after effect. The ingredients used in the medicine are acceptable and good for health.
  2. The generic medicine is of same strength than as of brand name medicine.
  3. The route of administration of generic medicine must be similar to that of brand name medicine such as if brand name medicine is for oral use then the generic medicine should be of nature i.e. oral.
  4. The generic medicine should indicate the same usage method as indicated on the brand name medicine.
  5. The shelf life of both the medicine should be same. In lay man language the expiry of generic medicine should be same as of brand name medicine.
  6. The generic medicine should be manufactured under the strict standard adhering with the batch requirement for identity, strength, purity and quality.

What is the estimated time period of FDA approval?

Generally, it takes six month or less than six months for the approval but it can vary in the case of complex medicine as the complexity makes it difficult to analyse. Aside from that the time period also vary according to the use of that drug as if the drug is of the kind that has a long term effect on public health needs more time for approval.

What are the measures to minimise FDA approval time?

In order to minimise the approval time the companies has to take the following measures:

  • Study well on FDA guidelines before creating the product or before submitting the application to the authorities.
  • Get in touch with the department by conducting meeting in which they can ask question related to drug development process.
  • The company should ensure that they submit the complete information required for the approval indication that the drug is safe, effective and substitutable to the brand name drug.

To cap it all, the concept of generic medicine largely deals with the health of public; therefore, it is essential to keep check on the approval process. The company should take effective measure to manufacture the drug in cost effective measure, so that it can be reachable to public at large. The pharmacists are directed to advice patients about the substitute available in the market at reasonable price with the similar quality and effectiveness.

-Surbhi Singla

Associate at Aggarwals & Associates, Mohali.


Clinical Research Regulation in India

Clinical Research Regulation in India

It is always necessary to assess the effectiveness and safety of medication research on humans, but one must be careful and diligent about how the participants in this sector carry out the procedure. The conduct of research involving human subjects must adhere to the principles of good clinical practises, or Good Clinical Practices (GCPs), including providing proper protection for such subjects.

According to the new Drugs and Clinical Trials Rules, 2019 (CT Rules, 2019) the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority, which is responsible to perform duties including clinical trial oversight, approvals, and inspections in India.  The Drugs Controller General of India (DCGI) is the Central Licensing Authority, which heads the CDSCO, and accountable for granting permission for clinical trials, and regulating the sale and importation of drugs for use in clinical trials. Additionally, as per Handbook for Applicants & Reviewers of Clinical Trials of New Drugs in India, Subject Expert Committees (SECs), which comprise experts dealing with relevant therapeutic areas, review the submitted clinical trial applications, study protocols and investigators’ brochures.

The majority of nations have made rules or regulations based on the principles of GCP. It is advised that people in India follow the GCP regulations set forth by the CDSCO.

Which law and regulation deal with clinical trial?

The Drugs and Cosmetics Act, 1940, CT Rules, 2019, Schedule Y for clinical research by CDSCO, ICMR and GCP guidelines are the legal enactments, which deal with clinical trials in India.

The CT Rules, 2019 are divided into 13 chapters (each including 107 provisions), and eight schedules. Clinical trials, bioequivalence and bioavailability studies, ethics committees, and experimental novel medications for human use are all covered by the new regulations.

By creating a time-bound application review process, increasing predictability and transparency of the regulatory system, and offering clarity on numerous complex topics, such as post-trial access, the new rules also aim to promote clinical research in the country.

What are the fundamentals of conducting a clinical trial in India?

In order to conduct clinical research, below mentioned steps are needed to be followed: –

  1. To seek approval from the DCGI
  2. To obtain permission from particular Ethics Committee where the clinical study is designed.
  3. Lastly, mandatory registration on the ICMR website.

What procedure is followed to approve the clinical trial?

In 2013, ‘three-tier’ review process has been implemented for approving clinical trials, so that time can be saved. According to the newly introduced process, Technical Committee is the authority, where application is reviewed at the beginning. Thereafter, Apex Committee scrutinizes the same after an initial approval from Subject Expert Committee. In the end, after receiving approval from all the three stages, DCGI will grant permission to conduct clinical trial.

What is the timeline for approval of clinical trial?

Previously, the timeline for approval of clinical trial from DCGI, was 06 months. However, as per CT Rules, such timeline has been reduced to 30 days where the clinical trial has to be conducted inside India. In case of clinical trial to be conducted abroad, period of 90 days is required.

What documents are required?

The following documents are needed for clinical trial in India: –

  • Clinical trial application form
  • Treasury challan
  • Source of bulk drugs
  • Information of chemicals and pharmaceuticals drugs
  • Pharmacology and Toxicology date of animals
  • Clinical pharmacology information
  • Regulatory conditions in other countries
  • Protocol for quality control and clinical study
  • Investigator’s brochure
  • Case report form
  • Patient data sheet and informed consent form
  • Investigator list in India and site address

Clinical Trial agreements:

Before the commencement of clinical trials, sponsor has to enter into clinical trial agreement with the investigator. The agreement must include the clauses such as financial support, fees, payment, and honorium. In addition to this, it must also state duties of sponsor towards GCP compliance, data reporting and recording and procuring necessary documents relating to trial.

Ethics Committee’s approval for review and approval for clinical trials:

It is compulsory for sponsor to obtain confirmation of EC analysis and approval for clinical trial. Before embarking upon the clinical trial, sponsor should collect the following information: –

  • Profiles of members of EC including name, address, qualification and experience.
  • GCP compliance confirmation.
  • Documented approval.
  • Copy of EC’s approvals in case it is based on changes
  • Copy of EC’s documents involving re-evaluation alongwith suggestions, any removals or suspensions of favorable opinion.

Registration for clinical trial:

Prior to starting a clinical study, the sponsor is required to register for one. The Indian Council of Medical Research’s Clinical Trials Registry, India (CTRI), received a clinical trial registration. Once the sponsor registered with the CTRI, the assigned REF number signifies that the clinical study was successfully registered.

Reporting clinical trial progress:

Periodically, study progress updates can be submitted to the EC by researchers, sponsors. The investigator may submit a periodic study report. There are two types of progress report i.e. annual report and final report.

Annual Report: – Sponsors are required to submit an annual clinical trial status report to DCGI. In the event that the trial was terminated early for whatever reason, the sponsor must provide a summary report within three months. The executive summary of the report comprises study information, the total number of participants exposed to the drug, the duration and dose of exposure, information on adverse drug responses that occurred in any circumstance, and the justification for stopping the trial.

Final report: – The final report is sent to the institution with the investigator’s signature and date on it along with a declaration that the study has been terminated. The EC and the sponsor also have to verify the veracity of the data. The entire data along with signature can be sent to sponsor and EC. For specific cases or if specified in the protocol, the presence of a coordinating investigator is taken into account when conducting a multicenter study.

Compensation and monitoring:

By keeping in view the primary objective of patient safety, compensation must be provided in case of any adverse event. Moreover, strict monitoring should be done against the same. Additionally, informed consent must state the process of monitoring as well as compensation in case of unfavorable event.

Apart from this, medical management should be provided to the subject in case any injury caused during the clinical trial due to the same. DCGI will decide the amount of compensation in cases such as permanent disability or death occurred during the clinical trial.

Conclusion: –

On the whole, the new regulations are thorough and well-balanced. They are also likely to raise the ethical and quality requirements for clinical trials nationwide, which will further benefit both the industry and patients. These regulations will assist in granting patients in India earlier access to medications by waiving local clinical trials. Local drug development will be encouraged by the presumed approval for clinical trials in 30 working days for indigenous medicines, which will help hasten the clinical trial process. It would increase predictability and confidence in the system to include provisions for rapid product approval under certain circumstances as well as pre and post submission with the CDSCO office.

-Kiranpreet Kaur

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali

Licenses required for manufacturing Cosmetics in India

Licenses required for manufacturing Cosmetics in India

Cosmetic is one of the important parts of pharmaceutical sector as it is associated with the health of public at large. In today lifestyle people are keen to use cosmetic products in various forms i.e. in the form of medicines, eatables and various products that are directly use on the skin to enhance the features. As the product is associated with the health of the public, licensing is required for manufacturing such kind of products and selling them in the market.

Meaning of cosmetics?

According to the Drug and Cosmetic Act, 1940, cosmetic means an article that can be used in any part of the human body. It may be rubbed, poured, sprinkled or sprayed on. It can be applied on any part of body to cleanse or for enhancing beauty. Mainly 11 categories of cosmetics are included under the preview of cosmetics according to the Schedule M-II of the Drugs and Cosmetic Act, 1940 namely powder, nail polishes and nail lacquers, Lipsticks and lip gloss, Depilatories, Preparations used for eyes, Aerosol, Alcoholic Fragrance Solutions, Hair Dyes, Tooth powder and tooth pastes, Toilet Soaps, Creams, lotions, emulsions, pastes, cleansing milk, shampoos, pomade, brilliantine, shaving creams, hair oils etc.

What are the different licences required for manufacturing cosmetics?

Every manufacturing business needs to get license before starting any business from the State Licensing Authority, and to start manufacturing cosmetic unit following licenses are required under the Drugs and Cosmetics Act, 1940: –

  • License on Form 32: Whoever wants to establish cosmetic manufacturing business, this license is required and it is submitted in the Form 31 provided in the legislation.
  • License on Form 32-A: For obtaining loan license for manufacturing cosmetics Form 31- A should be submitted.
  • License on Form 37: License for approval for carrying out test on cosmetics for manufacturing or raw material used in the manufacturing can be obtained by submitting the Form No.36.

The application fee for the above license is Rs.2500/- and Rs. 1000/- for inspection subsequently. Moreover, the license is valid for three years and after that renewal is mandatory for continuing the business.

What are the essential documents for obtaining manufacturing cosmetic license?

  • A self declaration form
  • NOC from Pollution Control Board
  • Plan the layout of the premises
  • Rent Agreement in case of rented premises
  • List of laboratory equipment
  • Applicant’s affidavit
  • Installed Machines

What are the other requirements for manufacturing cosmetic license?

Educational qualification to start a cosmetic manufacturing:

To establish cosmetic manufacturing unit, one must have to obtain license from the authority and for obtaining that licence it is required that at least one member of the staff is technical expert and posses following educational qualification vested in him/ her:

  • Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948, or;
  • Is registered under the Pharmacy Act, 1948,or;
  • Has passed the intermediate examination with one of the subject as chemistry or any other examination which is recognised by the Licensing Authority as equivalent to it.

Inspection before granting license:

Before granting license to any cosmetic manufacturing unit an Inspector is appointer under the Drugs and Cosmetic Act, 1940, to check all the necessary requirements such as mandatory requirements for premises, labelling etc., then prepare a final report and submit it to the Licensing Authority.  If after analysing the report submitted by the Inspector, the Licensing Authority came to the conclusion that the company fulfils all the required conditions, then licence is issued in favour of the applicant company.

-Surbhi Singla

Associate at Aggarwals & Associates, Mohali

Drug Regulations and Guidelines in India

Drug Regulations and Guidelines in India

Drug is an article intended for use in the form of chemical substances which act on the living system and used in different sectors for cosmetics and diagnosis, treatment, surgeries or prevention of diseases.  The main objective behind regulating the drug sector is to prevent the sale of low graded medicines and cosmetics as it can have adverse effect on the health of the public at large. Moreover, the regulation also covers the mandatory requirement to be involved in manufacturing and sale of drugs.

What regulatory body deals with drugs in India?


This is the principal regulatory body which controls the approval, production and pricing of the products. The organisation is headed by the Drug Controller General of India and is liable to work on the following matters:

  • Conducting clinical trials for new drugs.
  • Giving approval to the drug after quality testing.
  • Acts as Central Licensing Authority responsible for import of drugs and manufacturing licence approval.
  • Give guidance on technical matters.


The authority is established under the Ministry of Chemicals and Fertilisers in India. It is responsible for controlling drug prices in India and fixing minimum price for preventing black market and easy availability of drugs in the market.

What are the laws applicable on drugs?

The Drugs and Cosmetics Act, 1940:

The Act contains provisions related to the import, manufacture and distribution of goods in India. Moreover, various committees are established for proper implementation of the above stated Act such as Drug Consultative Committee, Technical Advisory Board, and Central Drug Laboratory etc.

The Drugs (control) Act, 1950:

The Act deals with fixing the maximum prices and their maximum quantities to be sold for a fixed price of a drug and also provisions are laid down for non compliance. In case the offence is committed by the company director, manager, secretary or any other member associated with management shall be liable unless he proves that the offence is committed without his knowledge. The offence committed with relation to the above Act should be investigated by the police officer not below the rank of inspector and there will be no prosecution for offence committed under this Act except with the previous sanction of District Magistrate.

The Cosmetic Rules, 2020:

The Act defines the basic rules for sale and manufacturing of cosmetics in India. Additionally the statute contains provisions related to import mechanism, their registration and other legal formalities. The cosmetic products which are already registered for sale in India can be imported by any person by making an application in online portal of the Central Government.


It is essential to regulate drugs is India as it covers the major sector of society. To ensure good health of nation a check on pharmaceutical sector is required to reduce the adulteration of drugs and assuring the good quality of drugs to the citizen of country at reasonable price. By following proper regulatory affairs at different stages of drug development, approval and marketing helps pharmaceutical companies to certify the quality, safety, and effectiveness of the drugs.

-Kishan Garg

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali

Do’s and Don’ts for Developers before Signing Service Agreement

Do’s and Don’ts for Developers before Signing Service Agreement

A service agreement is a written contract between a service provider and a client. It spells out the work to be performed and the responsibilities of both parties in getting the work done and paid for. Either party can be an individual or an organization. Service Agreement can be used for a single project, a job that terminates on a specific date, or a work that is going on.


  1. Requirements: For starting any work requirement is the utmost important feature in the contract as it defines the base for the contract i.e. what the project demands from the person with whom the developer is going to sign the said contract. In order to avoid confusion and misunderstanding in the future the requirements of the agreement should be well stated.
  2. Define Communication Channel: For the successful and effective completion of the project it is necessary that the communication methods are well defined whether the second party is living in the same city or from different city. Non effective communication leads to various loopholes in the upcoming project.
  3. State Intellectual Property Rights: Intellectual Property Right means the ownership rights of the product you create. To avoid future litigation on ownership rights it’s important to include IP rights in the Agreement before signing it.
  4. Define deadlines and work intervals: In order to complete the project on time it is necessary to well define the time limit and work intervals on which the project should be completed upto that task associated with it. For example if a contract is done for developing a software it must ensure that by what time the software will be ready for use.
  5. Payment Terms: Do explain the conditions of payment i.e. at what regular intervals it is required to be paid for the smooth functioning and timely completion of the project. The mentioned terms of payment will protect the developer from fraudulent activities and future disputes.


  1. Don’t ignore the possibility of complication: It is next to impossible that there will be no complication in the overall project so it is necessary to incorporate such acts in the contract which may arise by specifically using If and Then in the situations i.e. that if these circumstances arises then developer will do such things.
  2. Don’t Leave it unanswered: Don’t assume anything which is not stated in the contract because it will not serve the purpose of contract. Explain all the content and clauses of contract for better understanding.
  3. Don’t use vague, ambiguous words: Avoid using words that have more than one meaning, or make it difficult to understand the actual meaning. Instead of that use words that are easy to understand.

To sum up, the do’s and don’ts mentioned above are the general guidelines for making a good and enforceable contract. However, every case carries different situation so it is necessary to seek legal advice from the experts for effective enforceability of the agreement as well as to avoid disputes.

-Surbhi Singla

Associate at Aggarwals & Associates, Mohali.