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TMI BlogThe Cost Accounting Records (Pharmaceutical Industry) Rules, 2011X X X X Extracts X X X X X X X X Extracts X X X X ..... . 452, dated the 22nd April, 1988, except as respects things done or omitted to be done before such supersession, the Central Government hereby makes the following rules, namely: ‐ 1. Short Title and Commencement, - (1) These rules may be called the Cost Accounting Records (Pharmaceutical Industry) Rules, 2011. (2) They shall come into force on the date of their publication in the Official Gazette. 2. Definitions and Interpretations, - In these rules, unless otherwise requires,‐‐‐ (a) "Act" means the Companies Act, 1956 (1 of 1956); (b) "bulk drugs" means any pharmaceutical, chemical, biological or plant product including its salts, esters, stereo‐isomers and derivatives, which are used as such or as an in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease in human beings or animals and shall include any medicine included in any bona fide Allopathic, Ayurvedic, Homeopathic, Sidha or Unani (Tibb) systems of medicine; (j) "Generally Accepted Cost Accounting Principles" means the principles of cost accounting issued by the Institute; (k) "Institute" means the Institute of Cost and Works Accountants of India constituted under the Cost and Works Accountants Act, 1959 (23 of 1959); (l) "pharmaceutical activities" means production, processing, or manufacturing of bulk drugs or formulations and includes the meaning assigned to them under the Drugs (Prices Control) Order 1995 as amended from time to tim ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rules but not defined, and defined in the Act and rules made under clause (d) of sub‐section (1) of section 209 of the Act shall have the same meanings as assigned to them in the Act or rules, as the case may be. 3. Application, - These rules shall apply to every company, including a foreign company as defined under section 591 of the Act, which is engaged in the production, processing, or manufacturing of pharmaceutical activities and wherein, the aggregate value of net worth as on the last date of the immediately preceding financial year exceeds five crores of rupees; or wherein the aggregate value of the turnover made by the company from sale or supply of all products or activities during the immediately preceding financial year e ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... achieve optimum economies in utilization of resources and these records shall also provide necessary data which is required to be furnished under these rules. (5) All such cost records and cost statements, maintained under these rules shall be reconciled with the audited financial statements for the financial year specifically indicating expenses or incomes not considered in the cost records or statements so as to ensure accuracy and to reconcile the profit of all product groups with the overall profit of the company and the variations, if any, shall be clearly indicated and explained. (6) All such cost records, cost statements and reconciliation statements, maintained under these rules, relating to a period of not less than eight financ ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... es, he shall be punishable with fine, which may extend to five thousand rupees. (2) For contravention of these rules, ‐ (a) the company shall be punishable as provided under sub‐section (2) of section 642 of the Act; and (b) every officer thereof who is in default, including the persons referred to in sub‐section (6) of section 209 of the Act, shall be punishable as provided under sub‐sections (5) and (7) of section 209 of Companies Act, 1956 (1 of 1956). 9. Savings, - The supersession of the Cost Accounting Records (Bulk Drugs) Rules, 1974 and Cost Accounting Records (Formulations) Rules, 1988, shall not in any way affect‐ (a) any right, obligation or liabilities acquired, accrued or incurred thereunder; ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... best of my or our knowledge and belief were necessary for the purpose of this compliance report. 2 In my or our opinion, proper cost records, as per the Cost Accounting Records (Pharmaceutical Industry) Rules, 2011 prescribed under clause (d) of sub‐section (1) of section 209 of the Companies Act, 1956, have or have not been maintained by the company so as to give a true and fair view of the cost of production or operation, cost of sales and margin of all the products and activities of the company. 3 Detailed unit‐wise and product or activity‐wise cost statements and schedules thereto in respect of the product groups or activities are or are not kept in the company. 4 In my or our opinion, the said books and records gi ..... X X X X Extracts X X X X X X X X Extracts X X X X
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