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Health ministry to amend Section 71 of D&C Rules to make Pharm D professionals eligible to supervise drug manufacturing
While the agitation of pharmacy doctoral degree holders demanding creation of clinical pharmacist post in central and state health services continues, a key advisory body of the Central government on drugs is learnt to have approved a proposal to amend the Drugs and Cosmetics (D&C) Rules of 1945 to make Pharm D as one of the qualifications for competent technical staff to supervise the manufacturing of medicines. The move, which could help Pharm D graduates find employment in the pharmaceutical industry, was backed by the Drug Consultative Committee (DCC), following a representation from the Pharmacy Council of India (PCI).

As per Section 71 of the D&C Rules, drugs should be manufactured under the active direction and personal supervision of competent technical staff. At present, besides a graduate in pharmacy, a graduate in science or chemical engineering or chemical technology or medicine is also defined as a competent technical employee. However, the six-year pharmacy doctoral degree holders are not on this list. Since more than one lakh graduates are passing out from various pharmacy institutions in the country, the central council of the PCI has noted the need to amend the conditions for grant of drug production licence so that only graduates in pharmacy shall be defined as competent technical staff.

According to sources, though the PCI has sought to amend the rules making only pharmacy graduates or Pharm. D holders eligible to be technical staff to monitor drug manufacturing, the DCC has deliberated the matter and agreed for only adding Pharm. D also to the existing qualifications.

With many pharmaceutical companies declaring that the Pharm D graduates who did not study chemistry are ineligible, the government proposition could come as a relief for some graduates. However, many remain disappointed with the plan, stating that equating a doctoral degree with a bachelorís degree is absolutely unacceptable.

"We want inclusion of Pharm-D professionals in drug information offices and pharma covigilance centres in each hospital as per patient ratio to evaluate therapy and review treatment outcome. The government must make clinical pharmacy doctor cadre mandatory for National Accreditation Board for Hospitals and Healthcare Providers stamp of approval," Kerala Pharm-D Doctors and Parents Association President Simon Joshua told Pharmabiz.

"Drug safety is a basic human right and yet we don't have a system to monitor it at the hospital level. Drug safety solely depends on the experience of the doctor in the current healthcare scenario. Medication errors are causing many deaths, though very few are getting reported. Appointment of Pharm-D professionals would improve drug monitoring as they prepare medicine-related protocols, patient information leaflets, perform patient medication counseling and participate in ward rounds," Joshua, who recently staged a sit-in protest at Jantar Mantar in New Delhi to highlight the Pharm-D holders plight, pointed out.

While the government introduced the six-year Pharm-D course in 2008, no posts of clinical pharmacists were created in hospitals and health centres, putting the graduates in jeopardy. "These students spend a fortune and study for six years. After course completion, they find out that the job they want does not exist in the country. Their future is a real concern," an academician opined.

In the developed world, all hospitals appoint drug therapeutics panels, which include doctors, clinical pharmacists and nurses, to formulate standard procedures on administering drugs. With no such options available, thousands of Pharm D students are presently staring at an uncertain future.
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