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Duration of loan licence—An original loan licence in Form 25A or renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed: 2[Provided that if the application for the renewal of a licence is made before its expiry or if the application is made within six months of its expiry, after payment of the additional fees, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.

Certificate of renewal of licence in Form 25B. Conditions of licence in 2[Form 25 and Form 25F]. The records or registers shall be retained for a period of five years from the date of manufacture;. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency.

In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;] 8[ m the licensee, who has been granted a licence in Form 25F, shall— i forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to the manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing homes and Registered Medical Practitioners every three months;.

Date of issue 2. Name of the drug. Opening balance of stock on the production day. Quantity received, if any, and source from where received. Quantity used in manufacture. Balance quantity on hand at the end of the production day. Signature of the person in charge. B Accounts of production— 1. Date of manufacture. Batch Number. Quantity of raw material used in manufacture. Anticipated yield. Actual yield. Quantity of the manufactured goods transferred. C Accounts of the manufactured drugs— 1.

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Opening Balance. Quantity manufactured. Quantity sold. Name of the purchaser and his address. Balance quantity at the end of the day. Conditions for licence in Form 25B. The records or register shall be retained for a period of five years from the date of repacking. The licensee shall allow the Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed;] 5[ g the licensee shall maintain an Inspection Book, in Form 35, to enable an Inspector to record his impressions and the defects noticed;] 6[ h the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch.

In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture. Conditions of licence in Form 25A. The records or registers shall be retained for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed.

In case of drugs bearing an expiry date on the label the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. Forms of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C 1 2[excluding those specified in Part XB and Schedule X].

Loan licences. Form of licences to manufacture drugs specified in Schedules C and C 1 , excluding those specified in 2[Part XB and] Schedule X, or drugs specified in Schedules C, C 1 and X and the conditions for the grant or renewal of such licences.

Before a licence in Form 28 or Form 28B or Form 28D is granted or renewed, the following conditions shall be complied with by the applicant:—]]. Form of loan licence to manufacture for sale 2[or for distribution of] drugs specified in Schedules C and C 1 3[excluding the drugs specified in Schedule X] and conditions for the grant or renewal of such licence.

The records or registers shall be retained in the case of a substance for which a potency date if fixed for a period of two years from the expiry of such date, and in the case of other substances for a period of five years from the date of manufacture;]. In case of drugs bearing and expiry date on the label the reference samples shall be maintained for a period of three months beyond the date of expiry of potency.

In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;] 11[ n The licence, who has been granted a licence in Form 28B shall— i forward to the licensing authority of the concerned States of manufacture and supply of drug a statement of the sales effected to the manufacturers, wholesalers, retailers, hospitals, dispensaries, Nursing Homes and Registered Medical Practitioners every three months;.

A Accounts of the drugs specified in Schedule X used for the manufacture— 1. Date of issue. B Accounts of Production— 1 Date of manufacture. C Accounts of manufactured drugs— 1 Date of manufacture. Conditions of licence in Form 28A.

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Records or registers shall be retained, in the case of a substance for which a potency date is fixed, for a period of two years from the expiry of such date and in the case of other substances, for a period of five years from the date of manufacture. In case of drugs bearing an expiry date on the labels, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. Inspection before grant or renewal of licence.

The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardising and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the Technical Staff to be employed.

Report by Inspector. Procedure of licensing authority.

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Further application after rejection. Certificate of renewal of a loan licence. The provisions of this part shall apply to the manufacture of drugs for sale notwithstanding that such drugs are manufactured for sale outside India. Provisions for appeal to the State Government or Central Government by party whose licence has not been granted or renewed. Application for licence to manufacture Homoeopathic medicines. Form of licence to manufacture Homoeopathic medicines. Conditions for the grant or renewal of a licence in Form 25C. The licensee shall ensure to the satisfaction of the licensing authority that the products manufactured by it, conform to the claims made on the label.

The inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed alongwith the means to be employed or being employed for standardising and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Schedule M I read with the requirements of maintenance of records as laid down in Schedule U.

Grant or refusal of licence. Appeal to the State Government.

bolyarskiimoti.com/components/june-20/lamus-define-gemini-horoscope.php The glass shall be neutral as far as possible;. Storage and handling conditions shall also be properly observed by the licensee according to Homoeopathic principles; 4[ ea no colour shall be added to any Homoeopathic medicines: Provided that caramel may be added to combinations of Homoeopathic preparations with syrup base;]. Conditions relating to manufacture for examination, test or analysis.


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Labelling of drugs supplied to other persons. Form of application. Conditions of Licence. Cancellation of licences. Exemption of certain drugs from certain provisions of this Part. Prohibition of sale or distribution unless labelled. Manner of Labelling. The said particulars shall be indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein.

Labelling of medicines. Non-Sterile Surgical Ligature and Suture. Use of letters I. Prohibition against altering inscriptions on containers, labels or wrappers of drug. Packing of drugs. Packing of drugs specified in Schedule X. Diseases which a drug may not purport to prevent or cure. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer—the name and address of the seller:].

Lic No. C No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label.

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Prohibition of quantity and percentage. Name of substance. However, the licensing authority may, for any special reasons, direct the licensee to pre-sterilise such containers. The date of expiry shall be in terms of month and year and it shall mean that the drug is recommended for use till the last day of the month. Labelling of Medical Devices. Prohibition of sale of substance after prescribed date. Application of tests for sterility. The processes of taking samples from the batch for a test may be repeated twice: Provided that if the same organism is visible in more than one test the batch shall be treated as no sterile and the material container in the batch shall not be issued or used as part of a further batch unless and until it has been resterilized and has passed the tests.

Notwithstanding anything contained in the last preceding rule, in any case where— a a substance is required in any emergency by a registered medical practitioner, but the licensee has not filled containers in stock, or. Test for freedom from abnormal toxicity. Test for pyrogens. If water or any other aqueous solvent is supplied along with the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.

Substances specified in Schedule C 1. Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such subsequent application shall be fifteen thousand rupees: Provided further also that any application received after one year of the grant of approval for the manufacture for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees an such information and data as required by Appendix I or Appendix IA of Schedule Y, as the case may be.