61 cases of look-alike, sound-alike medicines brand reported in six months: Swati
- Azam Khan Swati said action for change of these brand names were taken by registration board of DRAP in light of mechanism devised by the board in 242nd meeting.
- The minister said that it described that if brand names/packaging design or color scheme of two products resemble, then later registration holder was bound to propose alternate names/packaging material for approval as one of condition of registration.
ISLAMABAD: Minister for Parliamentary Affairs Azam Khan Swati Tuesday said that total of 61 cases of look-alike and sound-alike brand of medicines were reported in last six months to Drug Regulatory Authority of Pakistan (DRAP).
During the question hour in the Senate, the minister said action for change of these brand names were taken by registration board of DRAP in light of mechanism devised by the board in 242nd meeting.
He said that it described that if brand names/packaging design or color scheme of two products resemble, then later registration holder was bound to propose alternate names/packaging material for approval as one of condition of registration.
The minister said but in some cases, later registration holder does not propose alternate names/packaging material.
Azam Swati said the board decided that in such cases DRAP would issue one reminder within 15-day time period and then manufacturing of the product would be stopped after approval of Chairman Registration Board.
He said that stoppage of manufacturing would be till approval of new brand name/packaging material, adding that list of such cases was prepared wherein firms were intimated for necessary rectifications regarding brand names, packaging designs and color schemes.
The minister said there were approximately 65,000 human medicines registered so far.
It was practically not possible to regulate color, shape and size of medicines.
He said typhoid fever was an endemic disease that had always affected people and cases of typhoid were reported from health facilities throughout the country via the District Health Information System (DHIS).
Azam Swati said around 7,16892 cases of typhoid reported through DHIS during the three years in 2016, 2017 and 2018.
He said that typhoid fever was normally sensitive to broad spectrum antibiotics available across the country. Since December 2016, the province of Sindh has been facing an outbreak of a Drug Resistant (XDR) typhoid fever.
The minister said this particular variant of typhoid was resistant to the drugs which were commonly used to treat typhoid fever.
The XDR variant has acquired genetic resistance to these drugs and was only sensitive to macrolides and carbapenem based antibiotics.
Hence it was not the case that drugs were not properly curing the disease, rather the resistant variety of the bacterium was resistant to the standard drugs used for treatment, he added.
He said the ministry had been involved in supporting the DoH, Government of Sindh in managing this outbreak since August 2018 and have organized multiple World Health Organization (WHO) missions of subject matter experts to analyse, characterize and assess the ongoing outbreak.
The minister said these WHO missions have subsequently developed a consensus based National Action Plan (NAP) for XDR typhoid with input from stakeholders from across the country.
Azam Swati said the pace of implementation of the Expanded Programme of Immunization (EPI) was encouraging and gaining momentum. Significant progress had been made towards improving immunization coverage all over the country as the government had taken several steps in this regard.
He said the federal EPI conducted Measles SIA in October 2018 targeting approximately 32 million children between 9 months to 5 years of age all over the country to improve the immunization coverage and reduce the burden of disease. As per third party validation, 93.3 % coverage was achieved.
The minister said in order to reach the defaulters and unimmunized children, special outreach immunization activities were conducted in December 2018 providing multiple antigens to the community covering 2,609,217 children in Sindh, Balochistan, Khyber Pakhtunkhwa and Islamabad.
Azam Swati said 46 low performing districts had been identified and an application for additional grant has been submitted to GAVI in May 2019 for improving immunization coverage.
He said that strengthening of cold chain capacity at national, provincial, district and union council levels through implementation of Cold Chain Equipment Optimization Platform (CCEOP) was being carried out. 6,782 CCE had been deployed in the country whereas, 8,218 would be deployed by 2021.
Uninterrupted supply of vaccines and logistics based on the census targets was ensured to prevent shortage of stocks at any level, the minister added.
Azam Swati said more than 500 vaccinators in Sindh, around 340 new vaccinators in Balochistan, 1800 new vaccinators in Khyber Pakhtunkhwa and 180 vaccinators in KP-TD (Khyber Pakhtunkhwa Tribal Districts) were recruited for improvement of immunization service delivery.
He said EPI management information system had been developed and was being rolled out to all provinces and areas for generation of timely and complete coverage data reports across the country.
He said the data quality assessments were carried out throughout the country to improve immunization data quality. Comprehensive EPI reviews were being carried out in the country to assess the performance of the programmes, identify gaps and suggest way forward to bridge the gaps.
To another question, the minister said it was submitted that multivitamins and pain-killers (except narcotic analgesics) were not prescription medicines (PoM) as per Drug Act, 1976 and Islamabad Capital Territory Rules, 2013.
Azam Swati said that hence they can be sold without prescription of the medical practitioner. The similar legal position exists in other provinces as well.
The minister said the estimated cost of Rs. 2000 million was reflected in PSDP for the fiscal year 2018-2019, however the National Preventive Health Programme was not yet approved by the Planning Commission till date.
He said there was no separate budget for Balochistan or any other province. The activities of the program would be carried out at national level and all provinces would be beneficiaries.