Uttarakhand Drug License
Uttarakhand Drug License
The State of Uttarakhand has witnessed extensive growth in the manufacture of drug formations, cosmetics, and diagnostic components. The phenomenon has resulted from a special industrial package which the Central Government announced in 2004 and the classification of the pharmaceutical industry as thrust industry considering the sensitive nature of the State’s provisions. This article educates the reader on the aspects of obtaining Uttarakhand drug license in detail.
The Concept of Licensing
The need for drugs can never be underscored, but the abundance of a commodity may potentially lead to its misuse. Hence, the government (both Central and State) issues drug license to endorse the operations of an organization dealing with the business of drugs.
Governing Regulations
India is governed by the Drugs and Cosmetics Act of 1940; the ambit of which includes the provisions for allopathic, ayurvedic or unani drugs.
Administration of Drug
The Central Drugs Standards Control Organization is India’s centralized drug control body, which enacts its provisions in coordination with the respective State Governments. In the state of Uttarakhand, the Uttarakhand Drugs Control acts as the administering body for this purpose.
Licensing in Uttarakhand – Conditions
In the State of Uttarakhand, licenses are issued for:
- Ayurvedic drugs
- Allopathic drugs
- Homeopathic drugs
- Cosmetics
- Repacking of drugs
- Blood and Blood products, or in other words, a blood bank
The best part of the article deals with the prerequisites for obtaining the above licenses, be it for a manufacturer or seller. Here’s a snapshot:
Ayurvedic Drug Manufacturing License
- The licensee must maintain sufficient records of the particulars concerning the manufacture of drugs and the tests conducted during the process (if any).
- The licensee must permit the inspector to conduct an inspection of the premises where the manufacture of the substance is being pursued. The former should also enable the authority to take samples of the raw materials and the finished products and allow him/her to inspect the records maintained for this purpose.
- The licensee must be in possession of an Inspection Book (in Form 35) to facilitate the inspector to record his/her impressions along with details of any defects discovered.
Allopathic Licenses
- The licensee is required to appoint and maintain the staff, premise, and equipment in accordance with the stated specifications.
- The licensee must be compliant with the provisions of the Act and the rules stated for the purpose.
- The applicant needs to conduct a lab test of the raw materials utilized for the manufacture of products and maintains records or registers conveying the details of such tests. These records or registers must be retained for a period of five years from the manufacturing date.
- The licensee should be in possession of records of the details of manufacture in accordance with the stated particulars of each batch of the drugs manufactured by him/her. These records must be retained for a period of five years.
- The licensee must facilitate the inspector to inspect the premises and analyze the plant and process of manufacture, as well as the means employed in standardizing and testing the drugs.
- The licensee must report to the licensing authority on any changes in the expert staff who are involved in the manufacture or testing of the drugs and any material alterations in the premises or plant used for certain purposes.
- The licensee must abstain from selling a particular batch of a drug if it is found to be non-compliant with the standards of strength, quality or purity stated by the rules.
- The licensee must maintain an inspection book in Form 35 to facilitate an inspector to record his/her analysis and the defects discovered during the process.
- The licensee must forward the licensing authority a statement of sales on a quarterly basis.
- The licensee must maintain accounts of all transactions with the essential details in a register bound. These records must be retained for a period of five years or one year after the expiry of potency, whichever is later.
- The licensee is required to maintain the drugs specified in Schedule X in a bulk form.
- The licensee must comply with the requirements of “Good Manufacturing Practices” as established in Schedule M.
Homeopathic Drugs
A homeopathic license is issued subject to the satisfaction of the following conditions:
- The premises of stocking of homeopathic medicines are maintained in a clean condition.
- The sale of Homeopathic drugs is pursued under the supervision of a person who is qualified to deal with these medicines.
- The holder of the license permits an inspector to inspect the premises and provide him/her with the required information.
- The applicant maintains the procurement records and sale of Homeopathic medicines comprising of alcohol with the names and addresses of the parties to the transaction.
Cosmetics
A cosmetic license is issued based on the following conditions:
- The licensee is providing and maintaining staff, premise, and equipment.
- The licensee complies with the provisions of the Act and the relevant rules.
- The licensee maintains records of the details of each batch of cosmetics manufactured and the raw materials used for manufacturing it.
- The licensee examines each batch or lot of the raw materials used for the manufacture of cosmetics, as well as each batch of the final product and maintains records or registers depicting the particulars pertaining to such tests. These records or registers must be maintained for three years from the date of manufacture.
- The licensee facilitates an Inspector appointed under the Act to inspect the premises of the former with/without prior notice.
- The licensee maintains an Inspection Book in Form 35 to facilitate an inspector to record the analysis and the discovery of any defects.
Repacking of Drugs
A license for the repacking of drugs is issued on the basis of the following conditions:
- The process of repacking of drugs is conducted under the personal supervision of at least one person who is approved as a competent person by the licensing authority.
- The licensee provides and maintains the adequate arrangements in his/her premises for conducting tests of the strength, quality, and purity of the drugs that is repacked.
- The licensee makes essential arrangements to maintain the drugs.
- The licensee complies with the provisions of the Act and the relevant rules.
- The licensee facilitates an inspector to examine the premise of repacking with or without prior notice.
- The licensee tests each batch or lot of raw materials utilized for the purpose of repacking, as well as each batch of the product which is repacked and maintains records of registers depicting the particulars pertaining to such tests.
Blood Banks
A Blood Bank will be issued licenses if found compliant with the stipulated requirements, which are as follows:
- The licensee appoints and maintains adequate staff, plant, premises, and equipment for the efficient functioning of the Blood Bank.
- The licensee conducts a test of his/her own blood in the laboratory and maintains the records and registers of such tests.
- The licensee facilitates the inspector to inspect the premises of the blood bank with or without prior notice, along with the records maintained under these rules.
- The licensee provides timely updates to the authorities concerned on the changes in the staff who are tasked with the operation of a Blood Bank, processing of human blood for components and/or manufacture of blood products and any other alterations in the particular premise or plant.
- No drug manufactured under the license should be sold without paying heed to the necessary precautions.
- The licensee must relinquish the stock of batch/unit which hasn’t passed the standard tests.
- Any bio-medical waste shall be treated, disposed of or destroyed in accordance with the provisions of The Bio-Medical Wastes (Management and Handling) Rules, 1996.
- The licensee does not indulge in collecting blood from any professional donor and/or manufacture of blood products from the blood drawn from such donor.
Apart from this, the blood bank should be in adherence with all the other mandatory procedures prescribed for every drug.
Recruitment Specifications
The common regulations convey that the medicines must be handled by a qualified pharmacist in a retail store, and a graduate with one year of experience or undergraduate with four years of experience in a wholesale store.
Layout Specifications
A pharmacy business can be opened in a carpet area of 10-15 square meters. The premises must be maintained at a clean, ventilated and cool storage facility; given that certain drugs, especially the likes of a vaccine, must be maintained in a low-temperature freezing zone. This mandates the requirement of a refrigerator and air conditioner.
Documents Required
The following documents must be furnished by the applicants of a drug license:
- Certificate of incorporation or registration.
- Memorandum and Articles of Association.
- Pan Card and canceled cheque leaf.
- List of directors, along with their photo ID and address proof.
- Board resolution.
- Affidavit from the directors.
- Curriculum vitae of the competent person.
- Appointment letter of the competent person.
- Proof of qualification.
- Experience certificate.
- Proof of identity of the pharmacist.
- Proof of address of the pharmacist.
- Affidavit of the pharmacist.
- Proof of ownership of the premises or rental agreement. In the case of the latter, a No Objection Certificate (NOC) must be produced.
- A sketch of the layout of the premises.
The Principle of Distinction
A drug business, if operated in more than a state, needs to avail registrations for each of its state of operation. The reason for such a ruling is that the provisions for these licenses vary between the different states.
Confused on the know-how of starting a drug business? Here’s your guide.
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