The frequently changing drug regulatory requirements badly impact the overall functioning of the drug distribution system of the country. On one hand while regulatory authorities feel that it would help in better regulation of the drug distribution system and effective implementation of the drugs and cosmetics act (D&C Act), the stakeholders feel that they are often being made scapegoats for the faulty implementation of bureaucratic decisions.
Chemists and druggist associations across the country feel that since they are not fairly represented at the centre, their views seldom get highlighted while making important decisions which affect the interest of the trade bodies.
The Federation of Gujarat State Chemist & Druggist Association (FGSCDA), a state affiliate of the 5,50,000 strong All India Organisation of Chemists and Druggists (AIOCD), pointed out that today the government pays short shrift to the needs of the trade associations which is the most important link of the drug distribution system. This affect their growth prospects further impacting the availability of drugs. The contribution of the retail chemists and pharma distributors and stockists from Gujarat in the overall pharma business in terms of percentage of sales compared to all India pharma sales, is approximately five to six per cent. The association spearheads the cause of over 14,000 members in Gujarat which consist of chemist, druggist, retailers and wholesalers .
According to Pradip Trivedi, secretary of the FGSCDA, it is disturbing to note that today the trade association who constitute the most important link of the drug distribution system does not have a voice at the centre. The recent regulatory decisions like the implementation of the new DPCO; ban of various drugs from the market etc was taken without taking into consideration the interest of the stakeholders which clearly shows that the trade associations have to abide by the whims of the industry or the government, he further pointed out.
Though the trade associations have been forthcoming with the new DPCO, they wanted to first sort out a number of lacunae. However, rather than taking up the matter judiciously, the government went ahead with a rash decisions further complicating the matter by enforcing new prices within 45 days of declaring the ceiling prices.
“It is needless to say that the issue of 45 days time frame set by NPPA for printing new prices on the old stocks had been a contentious issue from the very beginning, creating a lot of confusion among all the stake holders. What is more disturbing is the fact that as traders we have been left clueless on what our role was in this set-up. While the pharma companies insisted that it is impossible to recall and re-label the drugs within such a short time, the drug regulators desisted us from selling drugs, putting us in a spot. This lead to a lot of chaos, as there was a fear of availability of life saving drugs, as recalling stocks from villages and other remote areas needed much more time and elaborate planning,” he pointed out.
Proper implementation needed
The association feels that the government today lags in effective implementation of decisions. This has to be changed to get the desired results. Experts point out that while the government spends a lot of time and energy in formulating regulatory guidelines, it seldom think of effective ways to implement the same efficiently thus putting the whole effort into waste of time.
Trivedi stressed that it is the moral responsibility of the government not only to take important decisions, but also to effectively implement decisions. “There needs to be clear cut guidelines on the implementation aspect as well, so that the stakeholders are not left high and dry on the implementation part. Today, the government just notifies its decision and expects the industry to follow the rules and regulations as mentioned, without any guidance. How do you think we will we be able to cope up with this situation? Moreover the notification also reaches us late or through other sources unlike through an official source which further complicates the matter. All this needs to be changed if the government needs co-operation in the implementation aspect,” he adds.
The only viable solution to all these problems is a healthy representation of the stakeholders at all the decision making levels. By taking the stakeholders into confidence, the government will also be able to ensure effective and efficient implementation of its policies and regulations.
Building blocks
All said and done, having a cordial working relation with the regulators is a must for the smooth functioning of the business. In spite of having issues with the government on various levels with respect to the needs of the traders, FGSCDA’s relation with the state drug regulatory body, the Gujarat Food and Drugs Control Administration (FDCA), is a cordial one.
The state has seen a lot of collaborative initiatives between the association and Gujarat Food and Drugs Control Administration (FDCA), in the recent years for educating and sensitising traders and the public on various regulatory requirements and on the regulators expectations from the stakeholders. In fact, the FDCA have been updating itself to ensure better service to the stakeholders by adopting various technological interventions.
According to Dr H G Koshia, commissioner, Gujarat FDCA, understanding the needs of all the stakeholders who play a major role in the drug distribution system, had always been their key focus area. For this they have developed and integrated various online services and software for the benefit of the stakeholders.
One of the biggest examples of the same is the self-licensing software, Xtended Licensing and Laboratory Note (XLN) developed by the state drug regulatory body. The XLN software helps the regulators to perform their duties more effectively by enabling speedy disposal of various application while bringing in transparency to the system.
The beauty of this system is that it is tailor made to address not only the needs of the regulatory officials but also helps in bringing in more productivity. Through this software, the FDCA regulates the sales and manufacturing aspects related to drugs, food and cosmetics; issuance of licenses etc. The best feature of this software is that it enables the registration of all the pharmacists and chemists which prevents multiple illegal enrolments of pharmacists.
“Not only are we frequently in touch with all the stake-holders which include traders, distributors, wholesalers etc to get their views for improving our services for them, but we are also taking steps towards upgrading our existing services and technology so that they have no trouble in accessing us. We have taken all possible measures to have a give and take relation with all the stakeholders. As our office is always open for them , they can approach us any time they want to raise their grievances and issues. At the same time we are strict on proper and timely implementation of the D&C Act and Rules and other related provisions as safety and protection of the patients across the state is our primary concern,” informed Dr Koshia .
Dr Koshia further stressed that as a drug regulator of the state, he is fortunate to have the co-operation and collaboration of all the stakeholders when it comes to effective implementation of all the requisite rules and regulation within the state .
In the service of patients
FGSCDA as an association have been taking many initiatives to ensure better service to the patients. Over the years the association along with its parent body has been struggling to convince the Central government to adopt effective rules to force doctors to prescribe generics along with branded drugs so that patients were given a fair chance to opt for affordable choices. The association strongly feels that considering the alarming fact that doctors mostly prescribe branded drugs which are costly. The government needs to take a pro patient stand that will either force the doctors to prescribe both generic as well as branded drugs or they should give the pharmacist the right to dispense an alternative affordable drug to the patients wherever necessary.
Trivedi pointed out that today all the major drugs are available at lower prices in the market. However these drugs are seldom prescribed by the medical practitioners raising the question of accessibility of affordable medicines.
The association believes that it is high time to amend the rule 65 11 (a) of the D&C Act and make provisions in the law to empower the chemists and druggist to dispense cheaper alternatives to the one prescribed by the doctors. Only then will it be possible for the patients to get affordable medicines, Trivedi stressed.
Among the other demands, FGSCDA has been constantly voicing is to omit Schedule K (5) from the D&C Act, which deals with provisions with regard to drugs supplied by the registered medical practitioners to the patients directly.