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Towards a better pharma sector for quality drugs supply

Bhaskaran M
Wednesday, September 20, 2017, 08:00 Hrs  [IST]

This article proposes how to briefly deal with the issues faced by all the sectors in pharma field like trade, industry and public distribution system in healthcare sector. The author is prompted to write this article after seeing some articles in the earlier issue of this esteemed journal on GST and expired drugs. This is based on the experience of the author in the regulatory field for more than three decades and is not intended as fault finding or criticism. This article will deal only briefly with certain aspects which need attention and may not go into details of the issues for brevity. Broadly the areas can be grouped as under: Trade and its supply chain system; industry, and public sector procurement agencies.

Trade and supply chain system
Normally we hear about the comparison of system of drug sales in US and India. During my very brief stay in US,  I observed that some Schedule H drugs here are in OTC counter like Ibuprofen, Naproxen (in bulk pack100s). My limited understanding and enquiry with an Opthalmologist (with whom we stayed) reveal that prescription goes on line to the nearest Pharmacy for purchase with a provision for routing to another pharmacy. Can we have such a system with the prevailing condition. Are our pharmacies linked with doctors? Our pharmacies mostly cater to the floating population except hospital attached pharmacies. These pharmacies located within or adjacent to the hospital mostly procure drugs of the doctors choice leaving the patient no other place to go for purchase and also create unhealthy competitions due to heavy discounts offered to the doctors, have no importance to a registered pharmacist and sometimes reports of recycling of the drugs sold to patients admitted in the hospital. Further sale in a pharmacy in our country is linked to various external factors like social, economical, and above all the purchasing capacity for a full course of treatment along with reports of some section of doctors prescribing only limited quantity of an antibiotic drug for treatment. So with this brief comparison let us stop comparing our system with others for achieving better results here with reference to our local conditions.

The location of pharmacy is widespread catering to various segments of society, sometime like a general merchant. But are they regulated, the answer is sad “no” for various reasons. Taking this into account, I feel we can have a different categories of pharmacies as listed below.

OTC drugs (the present list may be expanded based on need and safety aspects)
The licence can be in Form 20.  This may not affect the existing traders who are having it as a livelihood instead of as a profession and these are not having a full time pharmacist, but run by family members. Since it will be only OTC drugs, may not need a prescription for sale. In case of initial illness, the patient can call his family physician and on his advice, just get the required drugs, as a first line of treatment. Since the focus nowadays will be on generic drugs supply, a registered pharmacist is a necessity for drug sale for patient safety.

Drugs specified in Schedule C & C1
Except high end latest antibiotics, and vaccines, Sera, and other biological items requiring cold storage at 8 °C to 25 °C and drugs other than those specified in Schedule C & C1

A new licence Form 20C and 21C may be created giving respectability and responsibility to the holder with relevant conditions. Minimum of two registered pharmacists may be made one of the licence conditions.

All categories of drugs including imported drugs for various types of life threatening conditions. Separate Form like 20D and 21D for this category may be formed with strict conditions on sale and distribution with relevant provisions for record keeping including prescription copy. This category may be subjected to regular and periodical inspections.

This licence may help in controlling sale of antibiotics causing drug resistance and in ensuring proper storage of drugs requiring cold storage. It will to a large extent ensure availability of imported drugs, which are now mostly through illegal channels without any price control at exorbitant costs, Issue of this category shall be restricted in number with location based on Metros and Tier 2 and Tier 3 cities only. This category may be linked online to the supplier/manufacturer effecting the sale and to concerned specialist prescribing the drug.

This may be a starting point towards a model in US, etc. Provisions may be made for patient counselling on various aspects of drug intake like drug dosage, food intake, contraindications etc with minimum of four pharmacists with at least one of them being qualified Pharm. D graduate or its equivalent with pharmacy practice/clinical pharmacy as specialisation.  

The current provision is silent on supply chain of drugs requiring cold storage with sometimes being sent without adequate storage provision on transit. It has been noticed that one imported drug in injectable form requiring cold storage (8°C-25°C)has not been tested for its efficacy starting from point of entry to ultimate sale during a three year period except once at one place. Nowadays manufacturers/suppliers take care in cold chain (earlier it was not seen), but not beyond. With no legal provision for compliance to cold chain and no testing, the efficacy of the drug consumed is questionable. Hence, this insistence on the cold chain need.  

Special provision may be made for import of drugs by these pharmacies with relevant price approval and display of these Imported drugs and their price prominently in the pharmacy at the entrance.

Both the above mentioned category B & C licencees may have their licences displayed prominently at the entrance of the pharmacy counter and the licence shall have provision for display of the photo of pharmacist. Currently photo provision is not in the licence, but is followed in Tamil Nadu and Karnataka.

Further, when we see all supermarkets/general merchants etc having a speedy sales without any wait in the counter due to provision of a bar code reading machines, it is a necessity for this sector to move towards it by the mandatory enforcement of a trace and track system for the manufacturers especially to control movement of spurious drugs

Industry
The pharma industry in India not only caters to the local, but also growing in export of drugs to other countries especially US & European countries following strict quality specifications. The boost needed may be in terms of clarity and incentives for SSI units to grow. SSI units are needed and have to grow for local supply and to keep competition in local procurement by public sector procurement agencies.

It will be useful if a SOP is prepared for:
(a) Regulators, both State and CDSCO, for various types of activities carried out by them. It may list the dos and donts by each agency clearly without any ambiguity for interpretations. At this point it is pertinent to mention here that during one of the DCC meetings (may be around 2010 or 2011) this was raised and a subcommittee was constituted for this. It is not known whether SOPs have been prepared for all the activities with a separate SOP for each of its duties [TN developed SOP for sale (both retail and whole sale licences), blood banks, RMI institutions]. SOP shall be clear including various circulars /instructions issued so far and any future circulars must be seen and clubbed to the relevant SOP provision. SOP may be separately issued both at State and Central level for drawl of samples and necessary follow up action on the same depending on the report of analysis (TN had a SOP for drugs reported NSQ). It is suggested that it shall be the responsibility of CDSCO to draw samples of all new drugs, vaccines, seras, items requiring cold storage like Insulin and other biologicals. Presently, it will be minimal due to lack of facilities at State level and lack of reference samples/method of analysis. Issue of SOP will help the Industry to a large extent without relying on hearsay or individuals opinion.

b) Though SOP is now in GMP for pharma units, the individual SOP of each units may be scrutinised for clarity and specificity and its adherence in all its activities.

The industry shall be made to have track and trace system (T&T system) for  all the drugs manufactured and distributed/sold by them. This is an urgent necessity in view of the recycling of expired drugs and movement of spurious drugs in the market. It may be enforced for all categories, whether for export or local sale and cost involved for this system cannot be an excuse for its non implementation, considering the public health at large. By moving towards a T&T system, we have to make necessary amendments in Drugs and Cosmetics Rules for simplification of labelling as it will be nearly impossible to have all the current requirements along with T&T system. Once it is created, it will naturally force sales outlets to have the required infrastructure.

Provision may be made in the Drugs and Cosmetics Rules for mandatory recall of drugs after its date of expiry and the industry shall take effective steps for the same. Based on the detection of recycling of expired drugs around 2010, a subcommittee was formed at a DCC meeting on framing regulations for recall and disposal of expired drugs. It is seen from the articles on GST & problems with expired drugs in Pharmabiz, no forward movement has taken place in this regard, in spite of its urgent need, irrespective of GST. Hence, there is an urgent need for a provision on expiry recall without any further loss of time.

Public sector procurement agencies
The procurement systems in government medical institutions have improved and come a long way from the earlier stages of local purchase, local quotation, local hospital tender, teaching institution tender and finally tender for the concerned Directorate in the Health Department. In this there was huge difference in rates quoted between different institutions, some time rate quoted being more than the MRP on the label.(it is fact, not fiction). Now most of the State governments have developed their own procurement system, after studying T N model (TNMSC), and modifying according to their local requirements/improvements. Here without going to detail, I will mention only the areas, where they can concentrate /improve as under.

a) Develop an essential drugs list (EDL) based on WHO list and with reference to the local need. This list may be revised each year based on feed backs and the quantity required. Assessment of quantity required is vital for the success of tender and procurement of the drugs. This EDL may be divided to two categories based on drugs. Which require BE/BA studies to ensure availability of quality drugs and to ensure participation of leading manufacturers.

Drugs which do not require the BE/BA study
b) Develop a robust quality control system to assure that all the drugs procured and supplied are quality approved and for public confidence (may be doctors also). This system shall have the motto “no compromise with quality” and report directly to the Head/MD of the procurement agency.

c) Quick and transparent payment system for all the supplies effected at a single point through NEFT for the supplies effected. This will ensure success of the system and may enable supply at lower rates.   

d) All procurement systems, whether well developed or developing, may have a system of periodical review by experts in the field, to study

I) compliance to the policies of the institution
ii) whether any deviation /dilution of its standards /procedures, reasons for the same and to find whether it is properly approved or individual based and if any observed, consequences of the same.
Iii) This review shall be independent of and in addition to any normal auditing as required by government/law. It is felt that it will help the organisation in the long run and in identifying the areas needed for improvement and this review may exclude the normal auditing as it is not its intention.
In this context it is suggested that the procurement agencies may consider (I) preference for local pharma units to cater to local need, but with no dilution in any other aspect, (ii) Pharma units set up/operated by pharma professionals, (iii) Develop and give preference to PSU units in supply to Central procurement agency and they may be requested/ordered to manufacture drugs for Jan Aushadhi shops so as to ensure continuous supply of quality drugs, (Iv.) The creation of hospital pharmacies, to start with at least in one tertiary hospital, to manufacture few non-sterile drugs, required for the hospitals around it to ensure continuous supply especially in emergencies. This is possible with availability of enough professionals in this field and performance based incentives being the criteria for them.

(Author is Director of Drugs Control, Tamil Nadu, Retd.Formerly consultant, TNMSC, Chennai)

 

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