Friday, September 2, 2016

06 - Legal & Regulation Updates - India

 Compliance Watcher


National Pharmaceutical Pricing Authority: Guidelines for Overcharging Cases
The National Pharmaceutical pricing Authority has issued Guidelines dated August, 19 2016 regarding identification and initiating action for recovery in cases of Overcharging by manufacturers and/or marketers under DPCO, 2013, DPCO, 1995 and DPCO, 1987.

Filing of Mandatory forms through IPDMS
The Ministry of Chemicals and fertilizers has issued a notice dated August 3, 2016 regarding the filing of mandatory forms through Integrated Pharmaceuticals Database Management System (IPDMS) under the provisions of DPCO, 2013 and discontinuation of submitting information in physical forms.

Special Economic Zones (Amendment) Rules, 2016
The Ministry of Commerce and Industry via notification dated August, 5th 2016 has issued the Special Economic Zones (Amendment) Rules, 2016 to amend the Special Economic Zones Rules, 2006.

Drugs and Cosmetics (5th Amendment) Rules, 2016
The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush) via notification dated August, 12th 2016 has issued the Drugs and Cosmetics (5th Amendment) Rules, 2016 to amend the Drugs and Cosmetics Rules, 1945. In the Drugs and Cosmetics Rules, 1945 Rule 161-B has been substituted.

Multi-State Co-operative Societies (Amendment) Rules, 2016
The Ministry of Agriculture and Farmers Welfare (Department of Agriculture, Co-Operation and Farmers Welfare) has notified the Multi-State Co-operative Societies (Amendment) Rules, 2016.

Drugs (Prices Control) Order, 2013
The Ministry of Chemicals and fertilizers, National Pharmaceutical Pricing Authority, through a Order dated August 17, 2016, has issued the Order to fix the prices of the scheduled formulations of drugs.

IRDA –Revival Option under discontinued Unit Linked Policies
The Insurance Regulatory and Development Authority of India (IRDA) vide circular dated August 26, 2016 has issued clarification on revival period applicable to policies under IRDA (Treatment of discontinued linked Insurance policies) Regulations, 2010.

Notice for seeking inputs/comments regarding Amendments of Chemical Accident Rules
The Ministry of Environment, Forest & Climate Change issued a notice dated August 8, 2016 for seeking inputs/comments regarding amendments of Chemical Accident Rules.

Clarification regarding online filing of returns by Exempted/Relaxed Establishments
The Employees Provident Fund Organization has issued a circular dated August 4th, 2016 regarding clarification on online filing of returns by Exempted/Relaxed Establishments.

Comply with the requirements of Good Manufacturing Practices and Good Laboratory Practices
The Central Drugs Standards Control Organization has issued a notice dated August 26, 2016 to Comply with the requirements of Good Manufacturing Practices and Good Laboratory Practices.

Upgradation of skill sets of persons employed in Pharma manufacturing units
The Central Drugs Standards Control Organization has issued a notice dated August 26, 2016 for upgradation of skill sets of persons employed in pharma manufacturing units.

Uttarakhand Vat- Uttarakhand Value Added Tax (Second Amendment) Act, 2016
Governor of Uttarakhand vide this notification has amended Uttarakhand Value Added Tax Act, 2005.

The Maharashtra Electricity Duty Act, 2016
The Government of Maharashtra via notification dated August 8th, 2016 has published The Maharashtra Electricity Duty Act, 2016 by repealing the existing Maharashtra Electricity Duty Act.
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