Sunday, 19 February 2017

Regulation in India #2

This post will focus on the regulation of homeopathic medicines in India rather than the activities of homeopaths. There may be a few omissions in this post as the legislation/regulations are rather large and complex. Also, it is to be noted that the original documents do contain errors.


Definition of "Homeopathic drug"
The legislation that is important here are the Drugs and Cosmetics Acts 1940 and the Drugs and Cosmetics Rules 1945. They are often presented together.
Part one of the Act 1940 has a definition of a drug -
(b) “drug” includes—
(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
(ii) such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ;
Schedule Two states -


Class of Drug
Standard to be complied with
4-A. Homoeopathic Medicines.

(a) Drugs included in the Homoeopathic Pharmacopoeia of India.
Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.
(b) Drugs not included in the Homoeopathic Pharmacopoeia of India but which are included in the Homoeopathic Pharmacopoeia of United States of America or the United kingdom or the German Homoeopathic Pharmacopoeia
Standards of identity, purity and strength prescribed for the drugs in the edition of such Pharmacopoeia for the time being in which they are given and such other standards as may be prescribed
(c) Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America, or the United Kingdom or the German Homoeopathic Pharmacopoeia.
The formula or list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed by the Central Government

Part four of the Rules 1945 deals with importation of drugs. It seems unlikely that homeopathic medicines would be imported into India in any great quantity if at all. Even so, it has some useful information in it.
Part IV - Import and Registration 
30AA. Import of New Homoeopathic medicine:  
(1) No new Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.  
(2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it. Explanation. —For the purpose of this rule, ‘New Homoeopathic Medicine’ means— 
(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia; or 
(ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or  
(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended.

The it is much more restrictive than might be expected. A "new homoeopathic medicine" is one that does not appear as a monograph in any of the mentioned Pharmacopoeia. Both the US and UK homeopathic pharmacopoeias are moribund. The Homeopathic Pharmacopoiea of the United States (HPUS) is online but access is expensive. The German pharmacopoiea . There is considerable overlap between these pharmacopoieas. The exact number of unique remedies is unknown but likely to be somewhere between 1300 to 2000 and more likely to be towards the lower end. Not the 3000 or even 5000 quoted in various places.

It's also a tautological definition. A homeopathic medicine is what certain homeopathic authorities say is homeopathic. This differs from, say, the EU definition that is based on methods and an amount of dilution. 

The processes for registering a "new homoeopathic medicine" will be discussed later.

Manufacture
The regulation of medicines is split between central and state government bodies in India. The Central Drugs Standard Control Organization (CDSCO) is national body that regulates pharmaceuticals (including homeopathic medicines, to a degree) and medical devices. Its remit is not that different from regulators such as the FDA and MHRA. It is responsible for the approval and licensing of pharmaceuticals but not homeopathic medicines.

Licensing of manufacturers happens at a state level - this diagram is very helpful in understanding the division of roles. This includes the licensing of homeopathic medicines manufacturers. The requirements for licensing of homeopathic medicine manufacturers can be found in Part Seven A of the Rules 1945. Much of it is uninteresting.


PART VIIA MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES
85E. Conditions for the grant or renewal of a licence in Form 25C−Before a licence in Form 25C is granted or renewed the following conditions shall be complied with by the applicant:— 
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee and who is— 
(a) a graduate in Science with Chemistry as one of the subjects with three years‘ experience in manufacture of Homoeopathic Medicines; or 
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or 
(c) holds qualification as defined under sub-clause (g) of clause (1) of section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines: Provided that the persons who are already in employment with five years‘ experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any licence granted in Form 25C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.
(2) The factory premises shall comply with the requirements and conditions specified in Schedule M-I:  
Provided that where the Licensing Authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing. 
(3) The applicant for manufacture of Homoeopathic mother tinctures shall either 
(i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or 
(ii) make arrangements with some institution approved by the Licensing Authority under Part XV(A) of these rules for such tests, wherever possible, to be regularly carried out on his behalf by that institution. 
(4) The premises where Homoeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes. 
(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine. 
(6) The applicant shall make arrangements for proper storage of Homoeopathic medicines manufactured by him: 
Provided that in case potentised preparations are made in a Pharmacy holding licence in Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the Licensing Authority that the products manufactured by it, conform to the claims made on the label.
Schedule M I is titled "GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR HOMOEOPATHIC MEDICINES". Good Manufacturing Practice (GMP) is very technical area - a detailed discussion would be extremely lengthy. It is worth noting that GMP standards do vary from country to country (although there is some harmonisation). The effectiveness of GMP inspection in India is moot. Inspections by foreign regulators often find non-compliance (see this example). It seems to be a systemic problem.

Part XV(a) relates to the approval of test laboratories and is not important in this context.

The last paragraph is somewhat opaque. It would appear that it allows a pharmacy with a Form 20-C licence to produce small amounts of homeopathic medicines that are made from a "back potency" (presumably purchased from a licensed manufacturer). A "back potency" is simply a less diluted form of a homeopathic medicine.

It is also permissable for a homeopath to compound homeopathic medicines for the use of their clients. It is not permissable for them to place them on the market.

New Products
The Act 1940 and the Rules 1945 do not say very much licensing of new homeopathic medicines.
85C. Application to manufacture "New Homoeopathic medicines." - the other provisions of these Rules Subject to 
(1) no "New Homoeopathic medicine" shall be manufactured unless it is previously approved by the Licensing Authority mentioned in Rule 21; 
(2) the manufacturer of "New Homoeopathic medicine", when applying to the Licensing Authority mentioned in sub-rule (1) shall produce such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.
(3) While applying for a licence to manufacture a "New Homoeopathic medicine" an applicant shall produce along with his application evidence that the "New Homoeopathic medicine" for the manufacture of which application is made has already been approved. 
Explanation. - The term "New Homoeopathic medicine" in this rule shall have the same meaning as in rule 30AA.
There is no definition of the minimum provings or the evidence required by the CDSCO. Examination of lists of medicines approved by the CDSCO do not seem to contain any homeopathic medicines. This press release suggests there is an appetite for some sort of regulation but there has been talk of this for some time. It has been suggested that the CDSCO is uninterested in homeopathic medicines.

The other route would be to submit a monograph to one of the above mentioned homeopathic pharmacopoieas. The UK one is moribund, the German presents a language barrier so HPUS and the Homoeopathic Pharmacopoeia of India (HPI - but be aware that the website has technical issues) are the obvious routes, the former doubly so if the manufacturer wishes to export to the US. HPUS will be discussed in a later post.

The requirements for monograph submissions to the HPI can be found here. Not particularly interesting except that it does by implication exclude some of the more fanciful remedies created by UK lay homeopaths known as Imponderables. It is not exactly clear where monographs should be submitted to on first reading but it turns out to be the Pharmacopoeia Commission of Indian Medicine and Homoeopathy. Which is part of the Ministry of AYUSH although there is no online evidence of such a Commission beyond a handful of mentions. Neither the Central Council for Research in Homoeopathy or National Institute of Homoeopathy make mention of it. However, the Commission is supposedly headed by a Dr Rajeev Kr. Sharma who is one of the authors of this paper and was at the time at the Homoeopathic Pharmacopoeia Laboratory (HPL) which may be part of the Ministry of AYUSH now although this is unclear. The Ministry of AYUSH was created in 2014.

Although no costs are mentioned in submitting a monograph, preparing a monograph to the standards required is time consuming and does require specialist skills, even if they are only being able to research literature and technical writing.

Whilst there does not seem to be any requirement to submit samples of a new homeopathic medicine for testing, regular testing of batches of homeopathic medicines is required to maintain GMP certification, presumably carried out by the HPL.


Packaging and Labelling
Rules 1945 partially deal with packaging and labelling.
PART IXA LABELLING AND PACKING OF HOMOEOPATHIC MEDICINES 
106-A. Manner of labelling of Homoeopathic medicines.— 
(A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed—  
(i) The words "Homoeopathic medicine",  
(ii) The name of the medicine— (a) For drugs specified in the Homoeopathic Pharmacopoeias of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.(b) For other drugs, the name descriptive of the true nature of the drugs. 
(iii) The potency of the Homoeopathic medicine — For this purpose the potency shall be expressed either in decimal, centesimal or millisimal systems.  
(iiiA) In case of Homoeopathic medicine containing two or more ingredients the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label. 
(iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer—the name and address of the seller: Provided that where such medicines are imported, the name and address of the importer shall also be mentioned on the label. 
(v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label: Provided that in case the total quantity of the pharmacopoeial homoeopathic medicine in the container is 30 millilitres or less, it will not be necessary to state the content of alcohol on the label. 
(B) In addition to the above particulars the label of a Homoeopathic mother tincture shall display the following particulars: − 
(i) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the words ―Batch No. or ―Batch or ― Lot Number  or ―Lot No. or ―Lot  or any distinguishing prefix. 
(ii) Manufacturing licence number, the number being preceded by the words ― Manufacturing Licence Number or ― Mfg. Lic. No. or ― M.L. Explanation.−This clause shall not apply to a Homoeopathic mother tincture manufactured outside India.  
(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label. 
106-B. Prohibition of quantity and percentage.–No Homoeopathic medicine containing more than 12% alcohol v/v (Ethyl alcohol) shall be packed and sold in packing or bottles of more than 30 millilitres, except that it may be sold to hospitals/dispensaries in packings or bottles of not more than 100 millilitres.

There do not seem to be any rules for the naming of combination homeopathic medicines. Nor do there appear to be any rules regarding what indications are permitted. However, there are advertising rules, which will be dealt with in the next post.

The Act 1940 itself does not mention homeopathic medicines but it does mention labelling.

17. Misbranded drugs.— 
For the purposes of this Chapter, a drug shall be deemed to be misbranded,— 
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of more therapeutic value than it really is; or 
(b) if it is not labelled in the prescribed manner; or 
(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
Interestingly, whilst the Act 1940 mentions that the Government can confiscate and prevent the sale of misbranded drugs, it does not set out specific penalties as if the case with adulterated or spurious medicines. Misleading labelling is certainly a problem - the EU got around it with allowing indications such as "used in the homeopathic tradition for the treatment of condition X" but there is no similar provision in Indian regulation as far as can be determined.

Patient Information Leaflets/Package Insert
In some jurisdictions, it is mandatory for medicines to come with a package insert that advises patients/consumers on the correct usage of a medicine and potential interactions and side effects. This is also the case in India but apparently not for homeopathic medicines.

Wholesale
The wholesaling of homeopathic medicines is dealt with along with sales.

Sale
Again, this is covered by the Rules 1945. Some of elements of the administrative process are of little interest and have been omitted here.

PART VIA SALE OF HOMOEOPATHIC MEDICINES 
67A. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified.  
(2) Application for the grant or renewal of a licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority... 
67B. A Licensing Authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licences and such other powers, as may be specified, to any other person under his control.
So, it is possible to apply to a central Licensing Authority (presumably the CDSCO) for a licence that allows the sale or wholesale distribution of homeopathic medicines. The CDSCO also has the power to delegate that authority, presumably in the same way as has been done with Manufacturing Licences. Strangely, no direct mention is made of any conditions/qualifications required. The Rules 1945 continue...

67C. Forms of licences to sell drugs. (1) A licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines by retail or by wholesale shall be issued in Form 20C or 20D as the case may be. 
67F. Condition to be satisfied before a licence in Form 20C or Form 20D is granted.-(1) A licence in Form 20C or Form 20D to to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are clean and in the case of a licence in Form 20C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines and who is in the opinion of the Licensing Authority competent to deal in Homoeopathic medicines:  
Provided that no registered Homoeopathic medical practitioner who is practising Homoeopathy in the premises where Homoeopathic medicines are sold shall deal in Homoeopathic medicines.

Form 20C is for sale, Form 20D distribution. The last paragraph is puzzling. Its meaning is unclear. It perhaps means that a homeopath can not sell homeopathic medicines themselves.
67G. Conditions of licence. Licence in Form 20C or 20D shall be subject to the conditions stated therein and to the following further conditions, namely: (1) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition. (2) The sale of Homoeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homoeopathic medicines. (3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed. (4) The licensee in Form 20D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol together with names and addresses of parties to whom sold.(5) The licensee in Form 20C shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol. No records of sale in respect of Homoeopathic potentised preparation in containers of 30 ml. or lower capacity and in respect of mother tinctures made up in quantities up to 60 ml. need be maintained.(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed. 
67GG. Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force as the case may be, documentary evidence in respect of the ownership or occupation or rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.
67-H. Cancellation and suspension of licences. (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder: Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the Licensing Authority− (a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or (b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or (c) if the act or omission was a continuing act or omission that he had not or could not reasonably have had knowledge of that previous act or omission, or(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.
Violations of the Act 1940 or the Rules 1945 can lead to suspension or cancellation of licences.

Both the Act 1940 and the Rules 1945 were originally formulated before the Internet. There is nothing in them that expressly forbids mail order. However, a manufacturer who wishes to sell directly to consumers would need a Form 19B or Form 20C licence. So would an online vendor, such as Amazon.in, would as well and it is likely that there are very many of them.

Export
There are no explicit regulations regarding the export of homeopathic medicines. 

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