Malladi Drugs & Pharmaceuticals Limited, Chennai. Title : SOP for Sales of Precursor Chemicals & Psychotropic Substances Prepared by :

Transcription

1 Review Date : July 2008 Page of Page 1 of PURPOSE This procedure sets forth guidelines for the approval of customers who purchase Ephedrine HCl, Pseudoephedrine HCl and its salts and Phenylpropanolamine HCl and Its Salts, Alprazolam, Lorazepam etc. 2.0 SCOPE A multi-part control effort is necessary to minimize sales Ephedrine HCl and its Salts, Pseudoephedrine HCl and its salts, and Phenylpropanolamine HCl and Its Salts, Alprazolam, Lorazepam etc. to anyone but to approved pharmaceutical manufacturers and approved traders / agents. The cornerstone of this effort consists of the customer approval process. All persons and entities requesting receipt of any quantity of Ephedrine HCl, Pseudoephedrine HCl and its salts and Phenylpropanolamine HCl and Its Salts, Alprazolam, Lorazepam etc. must have a Purchase Authorization letter on file to receive such material. Any new ship-to address is considered a new customer for purposes of these guidelines 3.0 RESPONSIBLITIES 3.1 Sales/Customer Service is responsible for establishing procedures for the sale of products listed above to approved manufacturers, and for ensuring that those procedures are followed. 3.2 Logistics is responsible to conformity of transaction in accordance with the procedures laid in this SOP. 4.0 PROCEDURE 4.1 The following information is gathered by Sales/Customer Service to perform the primary screening: End customers overseas a. Customer name and address (Corporate/Administrative Office and Consignee address) b. Purchase Order c. List of products(s) to be produced using requested material

2 Review Date : July 2008 Page of Page 2 of 7 d. Type and amount of material e. Original Import Permit f. Purchase Authorization g. Local Manufacturing Licence (or) any other licence to use the imported product in manufacturing into formulations etc h. End Use Certificate i. Customer s banker name and address Traders/agent overseas a. Customer name and address (Corporate/Administrative Office and Consignee address) b. Purchase Order c. Type and amount of material d. Original Import Permit e. Purchase Authorization f. Any Other license to deal this product g. List of customer to whom this product will be sold h. End Use Certificate from each of the End Users i. Customer s banker name and address j. Traders / agents should supply this product only to those end users whose names have been approved by Malladi Drugs & Pharmaceuticals Limited End customers in India A. Customer name and address (Corporate/Administrative Office and Consignee address B. Purchase Order C. List of products(s) to be produced using requested material D. Type and amount of material e. Copy of valid drug license with list of formulation using the purchase product

3 Review Date : July 2008 Page of Page 3 of 7 f. Copy of Sales Tax Registration Certificate g. Copy of Central Excise Certificate (If central excise is exempted in the area then declaration as per what rule it is exempted with notification number) h. Copy of Income Tax Pan i. Purchase Authorization j. Customer s banker name and address (Through whom the payment will be made) k. End Use Certificate Traders/agent in India A. Customer name and address (Corporate/Administrative Office and Consignee address B. Copy of Valid Trading Drug License in Form 20B / 21B0 C. Copy of Sales tax Registration Certificate D. Copy of Central Excise Registration Certificate E. Copy of Income tax Pan Number F. List of Customer to whom this material will be supplied and those customer s have been approved by Malladi Drugs and Pharmaceuticals Limited Customer s banker name and address Customer s statement of end-use signed by an Officer of the Company List of products(s) to be produced using requested material Type and amount of material 4.2 In addition the concerned marketing personnel will also undertake visits to the customers to ascertain the credentials of the purchaser as detailed below On site visit to the facility in India within 2 months of first sale On site visit to the facility Aboard within 6 month of first sale but in any case before subsequent sale

4 Review Date : July 2008 Page of Page 4 of 7 (Refer to Exhibit I for an example of the form letter of authorization to be sent to prospective customers.) 4.3 The above information obtained by Sales/Customer Service is reviewed by HOD of Marketing and who then authorizes, for servicing the requirement of the customer for shipment of above listed products. 4.4 All data is placed in the customer file. Prior to shipment, the Logistics Department must check (all the documents referred above) that the customer is authorized to receive above listed products. 4.5 If the customer requests shipment to a new location which is not the original location stated in the Purchase Authorization letter, documents as required under 5.1 will need to be collected from the customer. 5.0 EXHIBITS 5.1 Authorization Letter Exhibit I 5.2 Authorization Letter for a New Location Exhibit II Approval Signatures Date Originator Vice President (Marketing & Sales) Executive Director (Operations

5 Review Date : July 2008 Page of Page 5 of 7 End Of Procedure

6 Exhibit I Malladi Drugs & Pharmaceuticals Limited, No: 52, Jawaharlal Nehru Road, Ekkattuthangal, Chennai «Company» «Address1» «Address2» «City», «State», «PostalCode» Attn: Purchasing Date: Subject: Request for a Purchase Authorization Letter Dear Sir or Madam, The NDPS Act 1985 and our own international Standard Operation Procedure requires a "Purchase Authorization" letter on file for purchase of Ephedrine Hcl, Pseudoephedrine Hcl and its salts and Phenylpropanolamine Hcl and Its Salts, Alprazolam, Lorazepam etc. Please send us your letter of authorization covering the following A list people in your organisation authorized to purchase.. (please include names, titles, signatures, and telephone extensions). The material will be purchased for delivery to your manufacturing facility located at: The letter must state that you are fully aware of the Import regulations in the country of import and fully comply with them. Copy of Drug Manufacturing License in addition to the import permit(where applicable) Your bankers name and address If you are purchasing from us for the first time, we will require a "use" statement, (format enclosed) describing exactly how you will be using this material in your operation. Also, some company history/literature is required. This letter must be signed by a responsible officer of the company and on your company letterhead. This information can be faxed to my attention; however, it is essential we receive the original in the mail. Sincerely,

7 Exhibit II M/s. Malladi Drugs & Pharmaceuticals Limited No: 52, Jawaharlal Nehru Road, Ekkattuthganl, Chennai «Company» «Address1» «Address2» «City», «State», «PostalCode» Attn: Purchasing Date: Subject: Request for a Purchase Authorization Letter for a New Location Dear Sir or Madam, You have requested shipment of a Ephedrine Hcl, Pseudoephedrine Hcl and its salts and Phenylpropanolamine Hcl and Its Salts, Alprazolam, Lorazepham etc. to a new location which was not indicated on your original Purchase Authorization letter dated xx/xx/xx. The Chemical Diversion and Trafficking Act of 1988 requires Malladi Drugs and Pharmaceuticals Ltd to have "Purchase Authorization" letters on file for each location that Pseudoephedrine base and salts are shipped. Please send us your letter of authorization using the following format: Re: Purchase of (Specify the name of product) The material will be purchased for delivery to our manufacturing facility located at: A list of people authorized to purchase Pseudoephedrine Base and salts at the new location (please include names, titles, signatures, and telephone extensions). The letter must state that you are fully aware of the regulations in dealing with the purchase product and fully comply with them. Provide a description of the operation at the new ship-to location stating exactly how you will be using this material. Also, some company history/literature if not previously supplied. Attach a copy of Local Manufacturing License This letter must be signed by an officer of the company (and, of course, written on your company letterhead). This information can be faxed to my attention; however, it is essential we receive the original in the mail. Sincerely,