Even as the Parliamentary Standing Committee on Health and Family Welfare is still examining the new Drugs and Cosmetics (Amendment) Bill, 2013 that seeks to establish the Central Drugs Administration (CDA), experts in the pharmacy field have recommended for the inclusion of guidelines for Good Pharmacy Practice (GPP) in the proposed Bill.

The inclusion of guidelines for distribution and sale of medicines in terms of GPP is necessary as the safeguards are necessary during distribution and at the point of sale at retail/chemist shops with regard to scheduled and other drugs as well as mandatory requirement for filing prescriptions by registered pharmacists, recommended PD Sheth, an expert in pharmacy field and vice-president International Pharmaceutical Federation, The Hague.

In his submission to the committee, Sheth said that as per the amends of long title and preamble of the Drugs and Cosmetics Act, 1940, it is an Act to regulate the import, export, manufacture, distribution and sale of drugs etc. The Principal Act has already specified best practices under Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines. However, the Act is silent on GPP.

Sheth, who is also the past president of Indian Pharmaceutical Association (IPA), recommended to incorporate guidelines for Good Pharmacy Practice in community and hospital settings.   Compounders, developers and makers of medicines to providers of safe and effective medicine use should be referred to as "Pharmacist".

In practice settings, pharmacist’s profile has to be raised as ethical, value based and evidence led professional from traditional role in manufacturing, distribution and dispensing. Additional pharmacy assistants or pharmacy technicians should be deployed to work under the supervision of registered pharmacists.

Chemists, druggists and retail outlets, inpatient and outpatient hospital pharmacies should be referred as "Pharmacy", needing services of registered community or hospital Pharmacists. A well managed hospital pharmacy service has huge potential. There is a need to develop good hospital pharmacy in line with NHRC recommendations, Sheth in his recommendation to the Parliamentary committee said.

The Drugs and Cosmetics (Amendment) Bill, 2013 was introduced in Parliament on August 29 this year. However, the bill was not taken up for discussion by the Rajya Sabha till it adjourned sine die on September 6.  Later the bill was referred to the Parliamentary committee on September 9 for examination and report thereon within a period of two months.

Presently, the Parliamentary standing committee headed by Brajesh Pathak is examining the bill.

The new bill seeks to centralise licensing in 17 categories of very critical drugs included in the proposed Third Schedule of the Act. A separate Chapter containing regulatory provisions for medical devices and more comprehensive provisions for regulating clinical trials and exports are included in the bill.