http://www.pharmabiz.com/NewsDetails.aspx?aid=80244&sid=1  Need for coverage of mobile and migrant populations for prevention of polio

Shardul Nautiyal, Mumbai Friday, February 07, 2014, 08:00 Hrs  [IST]

With India being declared as a polio free nation on January 13, 2014 by the World Health Organization (WHO), experts point out that there is a need for coverage of mobile and migrant populations from countries like Burma, Pakistan and Afghanistan where polio cases have been detected. India can combat polio as Indian companies like Serum Institute of India and Bharat Biotech are capable of manufacturing polio vaccines of global standards. Informs Dr Sambhaji Zende, managing director, Haffkine Bio-Pharmaceutical Corporation, "India is on the way to make a paradigm shift from Oral Polio Vaccine (OPV) to injectables to make the vaccines more user friendly. Many European countries have adopted it and India would embrace the trend in the coming two years time." Though there has been a decline of 99 per cent in cases of poliomyelitis worldwide since 1988, India still needs to combat issues related to neglect of routine immunisation, immunity gap, lack of clinical and virological surveys and operational issues. Established in 1975 as a Government of Maharashtra undertaking to produce life saving vaccines, Haffkine Biopharmaceutical Corporation has a long history of indigenously manufacturing biological products. Since then, the company has come a long way and also set up a GMP facility that is pre-qualified by WHO for supply to United Nations Children's Fund (UNICEF). It was one of the first public sector vaccine manufacturing units to get a WHO accreditation for a trivalent OPV. It has three facilities in Maharashtra for different products. Located in the heart of the city, amidst various central and state research institutes and hospitals, the Mumbai facility manufactures the oral polio vaccine as well as the DPT vaccine.

FDA News

http://www.pharmabiz.com/NewsDetails.aspx?aid=79995&sid=1 Maha FDA files FIRs against pharmacists for doing dual employment

Shardul Nautiyal, Mumbai Saturday, January 25, 2014, 08:00 Hrs  [IST]

In order to deter pharmacists from selling their licenses to illegally run drug stores and taking up employment elsewhere, the Maharashtra Food and Drug Administration (FDA) has filed FIRs against 10 pharmacists in different cases of cheating and impersonation under different sections of CrPC of IPC across Maharashtra. Three pharmacists from Mumbai, two from Nanded, one from Pinjar, two from Thane and two from Nashik have been booked under section 416 for impersonation, 420 for cheating and 199 for violating the affidavit of oath (false statement made in any declaration which is by law receivable as evidence). The state FDA has also come across rampant violation of Drugs and Cosmetics (D&C) Act as several chemist shops in the state despite their licenses being canceled were found to be operating and dispensing drugs without any qualified pharmacist. Around 2500 cancellations and 1400 suspensions have been made across Maharashtra over a period of seven months due to absence of pharmacists at drug counters. Informs Sanjay Kale, joint vigilance commissioner, Maharashtra FDA, "We found that suspensions and cancellations have failed to make any impact as the drug store owners after getting penalised succeed in getting a stay on the matter from the appellate authority and continue with their illegal business.” "This is the outcome of the fact that there is a rising trend of qualified pharmacists selling their licenses to chemist shops and taking up dual employment either as a Medical Representative in a pharma company or as a faculty in an educational institution," he explains. Inspections done by the state FDA across Maharashtra over a period of seven months reported absence of pharmacists in 95 per cent of shops and in five per cent cases due to other reasons. Chemist shops across Maharashtra has been facing a massive crackdown by the state drug regulator in the past several months over absence of pharmacists and not maintaining proper billing records.