(7th October, 2014); Now in the near future, you may not see liquid orals in plastic containers because central government prohibits use of Polyethylene Terephthalate or Plastic containers for primary packaging of drug formulations in certain cases.
As per the rules published in G.S.R. 701(E) notification, 'No manufacturer shall use the Polyethylene Terephthalate or Plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group.'
Central Government proposes to make, in exercise of the powers conferred by clause (i) of sub-section (2) of section 33 read with section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), on the recommendation of the Drugs Technical Advisory Board. These rules may be called as Prohibition of Use of Polyethylene Terephthalate or Plastic containers for primary packaging of drug formulations for using in certain cases Rules, 2014.
Ministry is also highlighted that any manufacturer who contravenes the provisions shall be liable to penalty under the provisions of the Drugs and Cosmetics Act, 1940. These rules are likely to come in force after 180 days of publication of rules in Official Gazette.
Plastic containers are widely used in Indian pharmaceutical industry for liquid formulations and it will be surely affect all manufacturers. Now only future can tell on how industries react or follow the new stunning rules by government.
