What is form 44 cdsco? Where we can find it? or How to fill form 44?

Form 44 is the application form used in India to seek permission from the Central Drugs Standard Control Organization (CDSCO) for various activities related to new drugs. You can check this form on CDSCO website, follow the link for CDSCO form 44. Regacats is one of the most popular CDSCO consultancy and approval experts for cosmetic industry, handling CDCSO compliances, form 44 is one of the most crucial form that importers and manufacturers should care about, completing the compliances are necessary and it’s important you are not missing any information required in form 44.

Here are some of the key scenarios where Form 44 is used:

  • Import of a new drug: If a company wants to import a new drug into India, they need to submit Form 44 along with the necessary documentation to CDSCO for approval.
  • Manufacture of a new drug: Similarly, if a company intends to manufacture a new drug within India, they must apply for permission using Form 44.
  • Conducting clinical trials: If a company wants to conduct clinical trials for a new drug in India, they need to submit Form 44 to obtain the necessary permissions.
Form 44 is use 2

What are the specific criteria for CDSCO to approve a new drug?

CDSCO Drug Approval Process in India: Key Criteria for Approval
The Central Drugs Standard Control Organisation (CDSCO) is responsible for approving new drugs in India. To obtain approval, a new drug must meet specific criteria, which are outlined below:

1. Efficacy

  • Clinical Trials: The CDSCO requires clinical trials to demonstrate the efficacy of the new drug in treating the intended condition.
  • Statistical Significance: The results of the clinical trials must show statistically significant improvements in the treatment of the condition.
  • Comparative Efficacy: The new drug must demonstrate comparable or superior efficacy to existing treatments.

2. Safety

  • Risk-Benefit Analysis: The CDSCO conducts a risk-benefit analysis to ensure that the benefits of the new drug outweigh its risks.
  • Side Effects: The applicant must provide detailed information on potential side effects and risks associated with the drug.
  • Pharmacovigilance: The applicant must have a pharmacovigilance plan in place to monitor and report adverse reactions.

3. Quality

  • Good Manufacturing Practice (GMP): The manufacturing facility must comply with GMP guidelines to ensure the quality of the drug.
  • Quality Control: The applicant must demonstrate a robust quality control process to ensure the consistency and quality of the drug.
  • Stability Studies: The applicant must provide stability study data to demonstrate the shelf life of the drug.

4. Comparative Efficacy

  • Head-to-Head Trials: The CDSCO may require head-to-head trials comparing the new drug to existing treatments.
  • Indirect Comparisons: In some cases, indirect comparisons using historical data or meta-analyses may be accepted.
By meeting these criteria, a new drug can demonstrate its efficacy, safety, quality, and comparative efficacy, increasing its chances of approval by the CDSCO.

Essentially, Form 44 is the gateway for introducing a new drug into the Indian market. It serves as the primary application for companies seeking authorization from CDSCO for various activities related to new drugs.

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Key Information Typically Included in Form 44:

  • Details of the new drug (name, composition, dosage form)
  • Proposed indications for use
  • Manufacturing and quality control data
  • Clinical trial data (if applicable)
  • Safety and efficacy information
  • Proposed labeling and packaging

Note: The specific requirements for Form 44 may vary depending on the type of drug and the intended activity (import, manufacture, clinical trial).

It’s crucial to consult the official CDSCO guidelines and seek professional guidance to ensure accurate and complete submission of Form 44.

Disclaimer: This information is for general knowledge and guidance only. For the most up-to-date and accurate information, please refer to the official CDSCO website and consult with legal and regulatory experts.

Certainly, let’s break down Form 44 for you. This form is used to apply for permission from CDSCO for various activities related to new drugs, such as importing, manufacturing, or conducting clinical trials.

Here’s a breakdown of the key points:

  1. Applicant Information
  • Name of the Authorized Person: This refers to the individual or entity responsible for submitting the application.
  • Contact Information: Provide complete address, phone number, fax number, and email address for communication.
  1. Particulars of the Subject Drug
  • Generic Name: The common name of the drug (e.g., Paracetamol).
  • Brand Name: The specific brand name under which the drug will be marketed (e.g., Crocin, Dolo).
  • Composition: A detailed list of all the ingredients in the drug.
  • Specifications/Standards: Information about the drug’s physical and chemical properties, such as strength, purity, and stability.
  • Qualitative and Quantitative Particulars: Details about the amount of each ingredient in the drug.
  • Sterility and Stability Information: Data on the drug’s sterility and how long it can be stored without losing its effectiveness.
  • Labeling Details: Information that will appear on the drug’s label, including warnings, precautions, and dosage instructions.
  • Variations (if applicable): If the drug comes in different forms (e.g., tablets, capsules, injections), provide details about those variations.
  • Physician Manual and Promotional Literature: Any accompanying materials for healthcare professionals.
  • Packaging Description: Information about the drug’s packaging, including pack sizes.
  • Risk Classification: How the drug is classified based on its potential risks, as per international standards.
  • Accessories: If the drug requires any accessories for use (e.g., needles for injections), list them here.
  • Indication: The specific medical condition(s) for which the drug is intended to be used.
  • Manufacturer Information: Name and address of the company that will manufacture the drug.
  • Regulatory Status: Information about the drug’s regulatory status in other countries (e.g., approval status in the US, Europe).   
  1. Technical Data
  • Annex II: This section likely refers to a separate document that provides detailed technical information about the drug, such as analytical data, stability data, and pre-clinical studies.
  1. Fee Payment
  • Fee Amount: Specify the application fee amount.
  • Payment Details: Provide information about the payment made to the government, including the receipt number.
  1. Applicant Signature
  • The authorized person must sign and date the application.

Note:

  • This is a general overview, and the specific requirements for Form 44 may vary depending on the type of drug and the intended activity.
  • It is crucial to refer to the official CDSCO guidelines and seek professional guidance to ensure accurate and complete submission of the application.

CDSCO Moves to Online Submission for Veterinary Drug Applications:

  • Shift to Online Mode: The veterinary division of CDSCO has announced the transition of Form 44 submissions (for new drug import/manufacture and clinical trials) from offline to online through the Sugam Portal.
  • Affected Forms: This change includes applications for new drug permission for vaccines/drugs for bulk (Form 45A/46A), finished formulations (Form 45/46), and field trial permissions.
  • Online Submission Mandatory: Applicants are now required to submit all these applications through the online portal.
  • Part of Digitization Efforts: This move aligns with CDSCO’s ongoing efforts to digitize its regulatory processes, following previous shifts for PSUR submissions, PACs for human vaccines, and other applications.
  • Focus on Streamlining: The aim is to streamline regulatory procedures and improve efficiency for stakeholders.
  • Introduction of NSWS: The government has launched the National Single Window System (NSWS) to simplify business approvals, with a separate portal for the drug sector.
  • DDRS Initiative: CDSCO is also developing a Digital Drugs Regulatory System (DDRS) to create a unified digital ecosystem for all regulatory activities.
  • Benefits of DDRS: The DDRS aims to enhance trust, transparency, and accountability in drug regulation, improve quality and safety, and ensure compliance with Indian standards.

Key Takeaways:

  • This transition to online submissions marks a significant step towards digitizing drug regulatory processes in India.
  • The focus is on improving efficiency, transparency, and compliance within the pharmaceutical industry.
  • Stakeholders are encouraged to familiarize themselves with the online submission procedures and utilize the available platforms.
Following are the options available on the Applicant dashboard of SUGAM portal