Pharmaceutical Contract Manufacturing in India

As per Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945, if any substance falling within the definition of a drug (Section 3b of the Act) is required to be registered before import into the country. Not only the drug, but the manufacturing site also needs to be registered for import.Diphenoxylate Hydrochloride, 3810-80-8, Manufacturer

If the drug falls within the definition of New Drug (Rule 122 E of the Act), the new drug approval is the prerequisite for submission of application for Registration and/or import of drug. The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign manufacturer having a whole sale License in the country.

An application shall be made to the Licencing Authority in Form 40, either by the manufacturer himself, having a valid wholesale License, for sale or distribution of drugs or by his authorized agent in India either having a valid License to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs. Form 40 should cover the authorized signatory name, designation, department, along with the complete address of the Company (Manufacturing Site). The drug(s) brand name with different pack, pack size and/or different strengths of the same brand shall be captured. Importer‘s undertaking letter declaring for the information specified in Schedule D (I) (Module 1 of CTD format) and Schedule D (II) (Module 2 to 5 of CTD format), provided by the original manufacturer. The registration Fees amount (Challan number and date) shall be mentioned on Original TR 6 challan having complete name and address of the applicant and details of application to be enclosed. A copy of Whole Sale License of applicant & copy of Authorization letter of Applicant along with power of Attorney issued by the manufacturer should also be submitted.

Fee structure for Import Registration under Form 40

Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as registration fee for the Manufacturing premises. Applicant shall make an payment of 1000 USD (or its equivalent to Indian Currency), as registration fee for a single drug and additional fee of 1000 USD for each additional drug in case the manufacturing site remains the same. Fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other Bank, as notified, from time to time by the authority.

Applicant is liable to pay 5000 USD (or its equivalent to Indian Currency) for Expenditure [Inspection fees + expenditure on inspection to be borne by company] as may be required for Inspection or Visit of manufacturing premises. The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the central government in India or abroad, as required for examination testing and analysis of drugs. Applicant has to pay a fee of 300 USD (or its equivalent to Indian Currency) for a duplicate copy of the registration certificate, if the original is defaced, damaged or lost. Registration time provided further that if the application is complete in all respects and information specified in D (I) & D (II) are in order, the licencing authority shall within 9 months from the date of receipt of application issue such Registration Certificate, and in exceptional circumstances and for the reasons to be recorded in writing, the Registration Certificate may be issued within such extended period not exceeding 3 months as the licencing authority may deemed fit.

Copy of Inspection/ Audit Report latest carried out by National Regulatory Authority country of origin or other regulatory authorities like USFDA, MHRA, EU, and TGA. Number of countries where it is approved (should be a part of Plant Master File). If the drug is new drug, application for registration is to be made only after obtaining approval on Form 45 (as applicable). In case, the item considered as drug as per the definition of section 3 (b) of the Act in India but not registered as drug in the country of origin a legal undertaking from the manufacturer and approval of the item from the competent authority of the country of origin duly notarized and apostled should be submitted. The application of r-DNA products should be made separately as per the guidance document for submissions for biological. In case of bulk drug, if the same is approved in EU/USA etc. DMF approval number may mention on the covering letter itself. Renewal of registration or re-registration

At the time of application for renewal of registration or re-registration, the application is to be made 9 months before the expiry of the Registration Certificate. In addition regulatory documentary compliance like Form 40, POA, GMP/ COPP, Registration certificate, Plant Master File (soft copy, if no change), DMF (soft copy, if no change), License (sale or manufacturing License of drugs of the agent) etc.

209414-27-7, Efavirenz, Intermediate, Manufacturer

Ingenious Brandcare - Shree Ganesh Remedies Limited is an Indian Pharmaceuticals company and one of the proud subsidiaries of the Ganesh Group of Industrie which is presently having its headquarter in Ankleshwar in Gujarat