Experts call for amendment in D&C Act to make pharma graduates mandatory for technical jobs in pharma cos
Considering the huge potential of the technically qualified pharmacy graduates, the pharmaceutical manufacturing industry in India should adopt a policy to absorb only pharmacy graduates for the technical jobs for the drug production in the manufacturing plants. All the companies have by now upgraded their plants and equipments, but they are yet to upgrade their technical professionals, according to Dr Atmaram Pawar, HoD, department of pharmacy, Poona College of Pharmacy, Pune.
The government should consider amendment of Rules 71 & 76 of the Drugs and Cosmetics Act for a drastic change in the pharma production plants. Rules 71 (4-A) and 76 (4-A) should be replaced with ‘only a registered pharmacist with minimum qualification of degree in pharmacy’, through amendment, he said in a chat with Pharmabiz.
“At the time of framing the rules and regulations there were not sufficient number of pharmacy colleges in the country, hence there was shortage of pharmacy professionals. At present, the situation has drastically changed, and as a result more than sufficient number of professionally efficient pharmacists are available. They should be absorbed by the pharma companies. Today, several of the technical posts are occupied by science graduates,” Dr Pawar commented.
The government is enforcing good manufacturing Practices (GMP) in the pharmaceutical industry. US FDA approved companies are also working here. They all have upgraded their plants and machineries and upgraded the wing of technical professionals. But several other companies are still appointing science graduates. This should be changed because pharmacy profession is entirely a technical profession meant for pharmacy graduates who are competent in the field.
He commented that the company managers are preferring science graduates in place of pharma professionals because of saving expenditure on salary. The mindset of the industry doyens has to be changed in this respect.
“US FDA, WHO and equivalent regulations insist on pharmacy graduation as minimum qualification for a competent person for manufacturing of drug products. About 1000 of pharmaceutical manufacturing units approved by such regulations are operated in the country at present and they are all complying the strictures. However, those units which are not regulated by US FDA and WHO regulations and licensed under Schedule M of D&C Act 1940 by Indian FDA, manufacture drugs under the supervision of non-pharmacy people”, said Dr Pawar.
Drugs are poisonous substances that can be used to promote good health after thorough investigations and interventions by experts. Not only right diagnosis of disease by clinicians is needed, suggestions of right medicines are necessary to guarantee the safety of therapy. Proper assessment of prescription on the basis of pharmatherapeutics, pharmacovigilance and pharmacoeconomics during drug dispensing is equally vital.
These processes demand direct involvement of pharmacy qualified personnel as competent persons. Due to difficulties in getting sufficient number of pharmacy graduates, in 1940s drug & cosmetic law permitted science degree holders as substitutes for pharma graduates. Unfortunately, the situation is continued till date when there are about 1000 pharmacy colleges producing 40,000 pharmacy graduates and 7000 post graduates in pharmacy every year.