Three officials suspended for certifying drug as 'qualified'

Bengaluru, India 9 Sept 2014: The State Drugs Controller has recommended suspension of three officials – Junior Science Officer, Government Analyst and Chief Scientific Officer – for allegedly certifying a drug as ‘qualified’ despite negative report in the test and analysis.

Health and Family Welfare Department Principal Secretary N Sivasailam has submitted before Upalokayukta that the case will be entrusted to Lokayukta for disciplinary enquiry as per service rules.

An enquiry conducted by the Upalokayukta Justice Subhash B Adi had found that drug samples of Ccliya (Clomifene Citrate tablets) were certified as ‘qualified’ despite negative report in the test and analysis.

The complaint was that Chief Scientific Officer (CSO) Sudha Swamy had pressurised Government Analyst Mohammed Saifuddin Rubbani and Junior Scientific Officer Girish M K to prepare a positive report in the testing and analysis of the drug.

The drug samples of Ccliya, used in fertility treatment, was sent back to Government Analyst for repetition of test and analysis. After three repeated tests, CSO approved the report and the message was made known to retailers, wholesalers, manufacturers to prevent the sale of the drug.

However, one more test was conducted and the report was dispatched as “test passed.’’ Drugs Controller Raghurama Bhandary on Tuesday submitted a report stating all the three staff of the State Drugs Testing Laboratory were responsible for arbitrary and negligent testing.

“She (Sudha Swamy) has failed to report to higher authorities regarding approval of the test report as Not of Standard Quality and changing it to Standard Quality even after Not of Standard Quality report information had reached the public domain by way of SMSes and web publication,” the report said.

Upalokayukta Justice Subhash B Adi said the Principal Secretary has assured action within 15 days.

“In view of the submission by the Principal Secretary for Health and Family Welfare Department and promising action to be taken both of disciplinary enquiry as well as criminal proceedings if necessary against the officers, the matter has been posted for further hearing on September 30,” he said.

Track & Trace System for Domestic Drug Supply Chain In Nine Months

The government is hoping to see the implementation of the track and trace system for domestic and export supply chain in another one year as the National Informatics Centre (NIC) is on the task.

The NIC is preparing a software and it is likely to be finalised and implemented in nine months, going by the latest inputs to the commerce ministry. Once implemented, it will be able to track the drugs all throughout the domestic supply chain, senior official from the commerce ministry disclosed.

Apart from helping the domestic market, the system will be used to ensure the quality of drugs being exported from the country upto the point of port.   This will work as the technological authentication, along with the bardcoding system now in force for exports on secondary and tertiary packaging.

Though the report by a task force set up by the health ministry was submitted way back in 2012, no final decision was taken for a long time on its implementation. Now the government is learnt to have decided to go for the mechanism that would help any customer to trace all details of the product by reading the barcode with the help of devices like mobile.

However, the move has been faced with stiff opposition from a section of the industry and also the agencies like the National Pharmaceutical Pricing Authority (NPPA) which felt that the system was found to be inadequate and less comprehensive.

The task force, headed by Dr H G Koshia, had recommended the adoption of SMS model and unique identification code as an ideal method for the track and trace system as it was found to be more viable and affordable to the industry.

 “The task force, after detailed deliberation on the issue of track and trace and UID authentication, was of the considered view that in a country like India where multiple products are manufactured by a large number of companies, this would be a boon if applied. Initially there would be problems of application due to various reasons including financial and technical issues, but a beginning should be made so that ultimately the benefits of the system is available to all,” the task force said.

State issues guidelines for food safety in govt hostels

The Maharashtra State government has issued an order regarding food safety standards while preparing and serving the food in all hostels and residential schools across the state, run by the State’s Social Justice department. Pune has over 20 such hostels.

The directive was issued by the Social Justice and Special Aide Department on January 7 under the Central Government’s Food Safety Rule.

The Government Resolution (GR) mentions, “All hostel head should check safety standards as mentioned in the order and submit a report to their respective department heads. Department heads should conduct frequent meetings and review the situation.”

The GR also mentions certain sanitary and hygienic requirements to which food business operators should conform. ‘Premises on which food is prepared should have an overall hygienic environment. All new units should be set up well away from environmentally polluted areas.

There should be adequate space for manufacturing and storage, enough lighting and ventilation, with no flaking paint or plaster,’ the GR says.

‘Floors, ceilings and walls must be maintained — they should be smooth and clean,’ the GR adds.

Besides this, the government also has guidelines on the food preparation area, hand-washing facilities, toilets, personal hygiene, transportation and handling of food, raw materials, cross contamination, stock rotation, thawing of frozen products and others.

Rakesh Vitkar, in-charge of the Pune Municipal Corporation (PMC)-run Dr Babasheb Ambedkar student hostel claimed, “We have a capacity of 400 students.

We are already maintaining hygiene while preparing and serving food. However, we will go through the government order and see if anything is lacking. We welcome this move by the government. It will help to guide hostels on maintaining better hygiene.”

No need to relabel stock in market: Pharma cos to HC

The Delhi High Court has directed the National Pharma Pricing Authority (NPPA) to submit reply in respect of a proposal made by a slew of pharmaceutical companies who have argued that re-labelling of new prices notified as per the Drug Pricing Control Order, 2013, on the stocks available in the market is not required as long as drug companies publish and distribute revised price lists of their medicines.

The ministry of chemicals and fertilisers, through the NPPA, on May 15 last year, issued the new DPCO and granted a period of 45 days to Cipla and other pharma companies to revise downwards the prices of 348 drugs in the market as per the ceiling prices fixed by the government. Subsequently, the pharma companies challenged the 2013 DPCO notification before the high court.

However, after an order of the Supreme Court in December last year, the case of the pharmaceutical companies -- under which they had challenged earlier DPCO notifications of 1987 and 1995 — suffered a major blow. The apex court held that the drug firms will have to sell their current drug stocks in the market at the price provided by the regulator rather than at the older (higher) prices. The high court, for now, has granted time to the NPPA to file its reply and listed the matter for January 16.

As per the proposal, accessed exclusively by FE, the drug companies have claimed that re-labelling of the existing drug stocks in the market is not required as they have complied with the stipulations under various DPCO notifications mandating publishing and distribution of the revised price lists from time to time. Further, they also claim that the revised price lists have been circulated to dealers and state drug controllers, as required by the DPCO.

Additionally, they have also contended that the NPPA itself, in its documents, filed before the court has stated that there is no “mandatory” requirement to re-label new revised prices on products that have been already manufactured prior to the date on which the respective notification came into effect.

However, sources in the NPPA told this reporter that the proposal of the pharma companies refusing to re-label the available stock in the market is not acceptable to them and that, on the next date of hearing, they will submit to the court that the current market stocks should be relabelled as the same is in the interest of the consumers and in accordance with the directions of the Supreme Court.

FDA, Health Dept bust illegal blood trade in Rewari

In a joint operation, the Food and Drugs Administration and the Health department today claimed to have busted an illegal blood transfusion racket and seized blood from two private hospitals in Haryana's Rewari district.

A case has been registered against the two hospitals, an official spokesman said.

A joint team of FDA and Health Department officials raided Katyal hospital and Sanjiwani hospital in Rewari. During the raid, the team had also found that blood was being collected and transfused by a nursing staff without any test report.

They prima facie found that both the hospitals were involved in illegal trade of blood through agents and registered a complaint against the owners, the spokesperson said.

The illegal trade came to light when a team of the FDA and Health Department in Rewari jointly probed the matter of illegal blood seized at Katyal hospital on January 3, the official added.