A New Drug already approved in the country (within four years of approval of new drugs)
1. Form 44
2. Treasury Challan of INR 15,000 if all the active ingredients are approved in India for more than one year, or INR 50,000 in case any of the active ingredients is approved for less than one year.
3. Source of bulk drugs /raw materials:
4. Chemical and pharmaceutical information of API
a) Brief Chemical & pharmaceutical data
5. Data on Formulation
6. Regulatory status of the drug including names of the company’s marketing the drug in the country
7. Bioavailability/Bioequivalence study reports (for oral dosage forms)
Note: In following circumstances equivalence may be assessed by the use of in vitro dissolution testing:
a. Drugs for which the applicant provides data to substantiate all of the following:
i. Highest dose strength is soluble in 250 ml of an aqueous media over the pH range of 1-7.5 at 37°C
ii. At least 90% of the administered oral dose is absorbed on mass balance determination or in comparison to an intravenous reference dose.
iii. Speed of dissolution as demonstrated by more than 80% dissolution within 15 minutes at 37°C using IP apparatus 1, at50 rpm or IP apparatus 2, at 100 rpm in a volume of 900 ml or less in each of the following media:
a. 0.1 N hydrochloric acid or artificial gastric juice (without enzymes)
b. a pH 4.5 buffer
c. a. pH 6.8 buffer or artificial intestinal juice (without enzymes)
b. Different strengths of the drug manufactured by the same manufacturer, where all of the following criteria are fulfilled:
i. The qualitative composition between the strengths is essentially the same;
ii. The ratio of active ingredients and excipients between the strengths is essentially the same, or, in the case of small strengths, the ratio between the excipient is the same;
iii. The method of manufacture is essentially the same;
iv. An appropriate equivalence study has been performed on at least one of the strengths of the formulation (usually the highest strength unless a lower strength is chosen for reasons of safety); and
v. In case of systemic availability – pharmacokinetics have been shown to be linear over the therapeutic dose range.
c. In vitro dissolution testing may also be suitable to confirm unchanged product quality and performance characteristics with minor formulation or manufacturing changes after approval.
8. In case of Injectable formulation, sub-acute toxicity data conducted with the applicants’ product has to be provided.
9. Prescribing information Proposed full prescribing information and Draft of labels and carton
10. Copy of License in Form-29
The Periodic safety Update Reports (PSURs) of the new drugs are required to be submitted to the office of DCG(I) every six months for the first two years and for subsequent two years; the PSUR shall be submitted annually. The PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period.
The structure of PSURs as per schedule “Y”
- A title stating: Periodic Safety Update Report for the product, applicant’s name, period covered by the report, date of approval of the new drug, approved indication, date of marketing of new drug and date of reporting.
- Current worldwide market authorization status,
- Update of actions taken for safety reasons,
- Changes to reference safety information,
- Estimated patient exposure,
- Presentation of individual case histories,
- Other information,
- Overall safety evaluation,
- Appendix proving material relating to indication, dosing, pharmacology and other related information.
Dr. Manoj Karwa
Auriga Research Ltd.
Email: [email protected]
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