PHARMA LITERATI

The Drugs Controller General of India (DCGI) has warned of stern action against those manufacturers and marketers of pharmaceutical formulations who change the contents of the formulations without changing the existing brand names. In a circular, the national drug regulator has directed the state drug controllers and the zonal & sub-zonal officers of the Central Drugs Standard Control Organisation (CDSCO) to consider legal measures to discourage the unethical practice of marketing formulations by changing their contents without changing the existing brand names by the pharma companies.  The DCGI wants the enforcement officers and drug controllers to ensure that contents changed formulations are not marketed in the country in the old brand names as it confuses both the prescribers and patients. He wanted the licensing authorities not to permit to sell formulations with changed compositions without changing the old brand names. In the circular sent to all central...

The guidelines for storage of drugs are not being properly followed by manufacturers, distributors and retailers across the country leading to deterioration of the quality of medicines available in the market, sources in the Union health ministry has said. According to the sources, the ministry in its reply to a  Committee on Subordinate Legislation   over a representation on the issue, said that starting from  drug manufacturing  companies to distributors and chemists, nobody follows guidelines on drugs storage, properly leading to degradation of effectiveness of medicines and in many case s early expiry. The Drugs and Cosmetics Act and the rules specify in detail parameters on premises, surroundings, sanitation, storage of raw materials, documentation and  quality control systems   among others that a manufacturer is required to comply with under the conditions of licence, a senior  official   said. "The rules prescribe conditions...

The working pharmacists and regulatory officers across the country are planning to bring a proposal before the Drugs Consultative Committee (DCC) of the Union health ministry to make the registered pharmacists the sole authority to keep and sell medicines in the country. Their demand comes in the wake of the ministry's decision to amend D&C Rules to replace 'chemists & druggists' with 'pharmacy' to give retail trade a better professional recognition. They want the government to revoke Schedule K (5) in the D&C Act which mandates doctors to stock and 'supply' medicines to their own patients visiting their clinics or hospitals. The term 'supply' should be removed and the word, 'dispensing' should be inserted in the clause by specifying pharmacist's right to handle medicines even in clinics or hospitals run by medical professionals. In the next DCC meeting, expected to be held in May, the Drugs Controller of Odisha, Ma...